510(k) · Cleared

Cleared

Datascope 8FR. CO-Lumen 34 and 40CC Intra-Aortic Balloon Catheters for Optional Sheathless Insertion with Accessories

K980385510(k) TraditionalCleared May 1, 199888-day reviewClass II21 CFR 870.3535

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Datascope Corp. · DSP System, Balloon, Intra-Aortic And Control

Cleared on May 1, 1998 as substantially equivalent to K790775 (Datascope Corp., 1979) and 23 other predicates after an 88-day review. Its family tree reaches back 3 generations to 1990. 5 of the 52 devices in its family, counting itself, have a Class I recall. 17 later devices descend from it.

Decided: May 1, 1998
Review: 88 days
Class: Class II
Product code: DSP
Recalls: None
Predicates: 24

Its longest line of descent runs back 3 generations to K892222 (1990). 34 ancestors in all, the oldest K790775 (1979). 17 later devices descend from it, 2 citing it directly. 5 of the 52 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 3 generations backK892222 9.5F Percu Double Lumen Intra-Aortic BalloonKontron Instruments, Inc. · 1990
2 generations backK963187 Modified Labeling of Cardiac Assist Intra-Aortic Balloon Catheters…Boston Scientific Corp · 1996
1 generation backK972113 30 CC and 40 CC Sub-9 Nitinol and 30 and 40 CC Sub-9 Stainless SteelBoston Scientific Corp · 1997
This deviceK980385 Datascope 8FR. CO-Lumen 34 and 40CC Intra-Aortic Balloon Catheters…Datascope Corp. · 1998
Descendant · cites it directly · 15 of its ownK994157 Datascope's 8FR. Polymide 25CC,34CC and 40CC Iab and Accessories…Datascope Corp. · 2000
Descendant · 2 generations on · 14 of its ownK013326 Modification to: Datascope 8FR. Polyimide Alt B Iab, 25CC, 34CC…Datascope Corp. · 2001
Descendant · 3 generations on · 12 of its ownK031569 Datascope CA 40 8FR. Iabs, Model 0684-00-04XXDatascope Corp. · 2003
Descendant · 3 generations on · 11 of its ownK041281 Datascope 7.5FR. Iab Catheter and AccessoriesDatascope Corp. · 2004 · Recalled
Descendant · 3 generations on · 8 of its ownK063525 Datascope Fiber Optic Pressure Sensor Intra-Aortic Balloon Catheter…Datascope Corp. · 2007 · Recalled (Class I)

Showing 5 of 17 descendants. See all descendants

Descendants cleared per year

2000high 2 (2009) · low 0 (2005)2026

Class I recalls in this family

K063525 Datascope Fiber Optic Pressure Sensor…3 generations on · 2007
K112372 Cardiosave Hybrid Intra-Aortic Balloon Pump4 generations on · 2011
K181122 CARDIOSAVE Intra-Aortic Balloon Pump5 generations on · 2018
K151254 CARDIOSAVE Hybrid Intra-Aortic Balloon Pump5 generations on · 2015

Most influential descendants

Showing 5 of 17 · See all

K994157Datascope's 8FR. Polymide 25CC,34CC and 40CC Iab and Accessories, Models 0684-00-0327…Datascope Corp. · 2000 · cites it directly15descendants
K013326Modification to: Datascope 8FR. Polyimide Alt B Iab, 25CC, 34CC, 40CC, Datascope…Datascope Corp. · 2001 · 2 generations on14descendants
K031569Datascope CA 40 8FR. Iabs, Model 0684-00-04XXDatascope Corp. · 2003 · 3 generations on12descendants
K041281Datascope 7.5FR. Iab Catheter and AccessoriesDatascope Corp. · 2004 · 3 generations on11descendants
K063525Datascope Fiber Optic Pressure Sensor Intra-Aortic Balloon Catheter and CS300…Datascope Corp. · 2007 · 3 generations on8descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K892222	9.5F Percu Double Lumen Intra-Aortic Balloon	Kontron Instruments, Inc.	1990	—
−2	K963187	Modified Labeling of Cardiac Assist Intra-Aortic Balloon Catheters: Model 930…	Boston Scientific Corp	1996	—
−1	K972113	30 CC and 40 CC Sub-9 Nitinol and 30 and 40 CC Sub-9 Stainless Steel	Boston Scientific Corp	1997	—
0 (this device)	K980385	Datascope 8FR. CO-Lumen 34 and 40CC Intra-Aortic Balloon Catheters for…	Datascope Corp.	1998	—
+1	K994157	Datascope's 8FR. Polymide 25CC,34CC and 40CC Iab and Accessories, Models…	Datascope Corp.	2000	—
+2	K013326	Modification to: Datascope 8FR. Polyimide Alt B Iab, 25CC, 34CC, 40CC…	Datascope Corp.	2001	—
+3	K031569	Datascope CA 40 8FR. Iabs, Model 0684-00-04XX	Datascope Corp.	2003	—
+3	K041281	Datascope 7.5FR. Iab Catheter and Accessories	Datascope Corp.	2004	7
+3	K063525	Datascope Fiber Optic Pressure Sensor Intra-Aortic Balloon Catheter and CS300…	Datascope Corp.	2007	Class I

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1979	1	0
1982	1	0
1990	2	0
1991	3	0
1993	4	0
1994	3	0
1995	7	0
1996	7	0
1997	3	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2000	1	0
2001	1	0
2002	1	0
2003	1	0
2004	1	0
2006	1	0
2007	1	1
2009	2	0
2011	2	1
2012	1	0
2013	1	0
2015	1	1
2017	2	1
2018	1	1

FIG. 1 — Lineage of K980385, 1990–2018Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

5 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new DSP device

#1 K250542 AC3™ Range™ Intra-Aortic Balloon Pumpscore 11.2 · 8 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (24)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K790775	Intra-Aortic Balloon, Type S Summary page 2 …PREDICATE DEVICE INFORMATION Datascope's 8Fr. Co-Lumen 34 & 40cc IABs for Optional Sheathless Insertion are substantially equivalent to the devices as described in: 1) K790775 - Datascope Type “S” IAB. 2) K905056 - Datascope Percor STAT-DL 9.5Fr. IAB with Optlonal Insertion without ... . ... . .anIntrod…	Datascope Corp.	1979	—
*	K905056	Percor Stat-DL 9.5 FR W/Opt Insert W/O Intro Sheat Summary page 2 …e's 8Fr. Co-Lumen 34 & 40cc IABs for Optional Sheathless Insertion are substantially equivalent to the devices as described in: 1) K790775 - Datascope Type “S” IAB. 2) K905056 - Datascope Percor STAT-DL 9.5Fr. IAB with Optlonal Insertion without ... . ... . .anIntroducer Sheath. . 3) K910997B - Datascop…	Datascope Corp.	1991	—
*	K910997	Datascope Percor Stat Intra-Aortic Balloon Summary page 2 …ribed in: 1) K790775 - Datascope Type “S” IAB. 2) K905056 - Datascope Percor STAT-DL 9.5Fr. IAB with Optlonal Insertion without ... . ... . .anIntroducer Sheath. . 3) K910997B - Datascope Percor STAT Intra Aortic Balloons with Alternate Coating. 4) K911000 - Datascope Percor STAT Co-Lumen 8.5Fr. 40cc IA…	Datascope Corp.	1991	—
*	K911000	Percor Stat DL 8.5 FR 40CC Intra-Aortic Balloon Summary page 2 …T-DL 9.5Fr. IAB with Optlonal Insertion without ... . ... . .anIntroducer Sheath. . 3) K910997B - Datascope Percor STAT Intra Aortic Balloons with Alternate Coating. 4) K911000 - Datascope Percor STAT Co-Lumen 8.5Fr. 40cc IABs. 5) K914802 - Datéscope Percor STAT-DL 9.5Fr. 34cc IAB Sheathless Insertion. 6…	Datascope Corp.	1993	—
*	K914802	Datascope Percor Stat DL9.5 FR34CC Intra-Aort Ball Summary page 2 …nIntroducer Sheath. . 3) K910997B - Datascope Percor STAT Intra Aortic Balloons with Alternate Coating. 4) K911000 - Datascope Percor STAT Co-Lumen 8.5Fr. 40cc IABs. 5) K914802 - Datéscope Percor STAT-DL 9.5Fr. 34cc IAB Sheathless Insertion. 6) K940178 - Datascope Percor STAT-DL 9.5Fr. 34cc & 40cc IABs…	Datascope Corp.	1993	—
*	K940178	Percor Stat-DL 9.5 FR.34CC & 40CC /Percor Stat-DL 10.5 FR.40CC & 50CC Intra-Aortic… Summary page 2 …ons with Alternate Coating. 4) K911000 - Datascope Percor STAT Co-Lumen 8.5Fr. 40cc IABs. 5) K914802 - Datéscope Percor STAT-DL 9.5Fr. 34cc IAB Sheathless Insertion. 6) K940178 - Datascope Percor STAT-DL 9.5Fr. 34cc & 40cc IABs with an alternate inner lumen of 80/20 hard/soft Estane 7) ' K940231- Datasc…	Datascope Corp.	1994	—
*	K940231	Intra-Aortic Balloon for Optional Sheathless Insertion Summary page 2 …AT-DL 9.5Fr. 34cc IAB Sheathless Insertion. 6) K940178 - Datascope Percor STAT-DL 9.5Fr. 34cc & 40cc IABs with an alternate inner lumen of 80/20 hard/soft Estane 7) ' K940231- Datascope Percor STAT-DL 9.5Fr. 40cc IAB with an alternate membrane material; a Polyurethane/Silicone blend. &) K960166 - Datas…	Datascope Corp.	1994	—
*	K960166	Percor Stat-DL 9.5 FR. 34 & 40CC Summary page 2 …ate inner lumen of 80/20 hard/soft Estane 7) ' K940231- Datascope Percor STAT-DL 9.5Fr. 40cc IAB with an alternate membrane material; a Polyurethane/Silicone blend. &) K960166 - Datascope Percor STAT-DL 9.5Fr. 34 & 40cc IABs for Optional Sheathless Insertion with Alternate Inner Lumen Material (Texin).…	Datascope Corp.	1996	—
*	K960713	8 FR.-40CC Arrow Flex Intra-Aortic Balloon Catheter with Blue Flex Tip, Product Number… Summary page 2 …yurethane/Silicone blend. &) K960166 - Datascope Percor STAT-DL 9.5Fr. 34 & 40cc IABs for Optional Sheathless Insertion with Alternate Inner Lumen Material (Texin). 9) K960713 - Arrow International 8Fr. 40cc NarrowFlex™ JAB (nitinol inner lumen) K961358 - Arrow International 8Fr. 40cc NarrowFlex™ IAB fo…	Arrow Intl., Inc.	1996	—
*	K961358	Arrow Sheathless Intra-Aortic Balloon Catheter Summary page 2 …cc IABs for Optional Sheathless Insertion with Alternate Inner Lumen Material (Texin). 9) K960713 - Arrow International 8Fr. 40cc NarrowFlex™ JAB (nitinol inner lumen) K961358 - Arrow International 8Fr. 40cc NarrowFlex™ IAB for sheathless insertion (nitinol inner lumen) 11) K963865- Arrow International…	Arrow Intl., Inc.	1996	—
*	K963865	8 FR. -30CC Narrowflex Sheathless Intra-Aortic Balloon Catheter, Product Number Iab-04830S Summary page 2 …International 8Fr. 40cc NarrowFlex™ JAB (nitinol inner lumen) K961358 - Arrow International 8Fr. 40cc NarrowFlex™ IAB for sheathless insertion (nitinol inner lumen) 11) K963865- Arrow International 8Fr. 30cc NarrowFlex™ IAB (nitinol inner lumen) K961358 - Arrow International 8Fr.30cc NarrowFlex™ IAB for s…	Arrow Intl., Inc.	1997	—
*	K964987	Datascope Percor Stat - DL 9.5 FR. 25 and 40CC Intra-Aortic Balloon for Optional… Summary page 2 …International 8Fr. 30cc NarrowFlex™ IAB (nitinol inner lumen) K961358 - Arrow International 8Fr.30cc NarrowFlex™ IAB for sheathless insertion nitinol inner lumen) 12) K964987 - Percor STAT-DL 9.5Fr. 25 & 40cc IABs for Optional Sheathless Insertion and Percor STAT-DL 10.5Fr. 40 & 50cc IABs for Sheath Ins…	Datascope Corp.	1997	1
*	K972113	30 CC and 40 CC Sub-9 Nitinol and 30 and 40 CC Sub-9 Stainless Steel Summary page 2 …0.5Fr. 40 & 50cc IABs for Sheath Insertion with Alternate Inner Lumen Material (80/20 hard/soft Estane) & Alternate Membrane Material (Polyurethane/Silicone) blend. 13) K972113 - Boston Scientific Corp. Sub-9 Nitinol 30cc and 40cc IAB for Sheathless Insertion (nitinol inner lumen) All of the above refere…	Boston Scientific Corp	1997	—
*	K820834	Percor Percutaneous Introducer Summary page 3 …atascope’s 8Fr. Catheter Introducer and Stepped Vessel Dilator for use with the insertion of the 8Fr. IAB is substantially equivalent to the devices as described in: 1) K820834- Datascope’s 10Fr. Percor Percutaneous Introducer with Hemostasis Valve ... 2) . K902674- Datascope’s Arterial Cannula with Acce…	Datascope Corp.	1982	—
*	K902674	Datascope Arterial Cannula W/Access Port Summary page 3 …of the 8Fr. IAB is substantially equivalent to the devices as described in: 1) K820834- Datascope’s 10Fr. Percor Percutaneous Introducer with Hemostasis Valve ... 2) . K902674- Datascope’s Arterial Cannula with Access Port. . . 3) K904476 - Datascope’s 5 to 9 Fr. Stepped Vessel Dilator 4) K904477 - Datas…	Datascope Corp.	1991	—
*	K904476	Vessel Dilator Summary page 3 …escribed in: 1) K820834- Datascope’s 10Fr. Percor Percutaneous Introducer with Hemostasis Valve ... 2) . K902674- Datascope’s Arterial Cannula with Access Port. . . 3) K904476 - Datascope’s 5 to 9 Fr. Stepped Vessel Dilator 4) K904477 - Datascope’s Stiff Guidewire for use with Datascope IABs 5) K924607…	Datascope Corp.	1990	—
*	K904477	Guidewire Summary page 3 …eous Introducer with Hemostasis Valve ... 2) . K902674- Datascope’s Arterial Cannula with Access Port. . . 3) K904476 - Datascope’s 5 to 9 Fr. Stepped Vessel Dilator 4) K904477 - Datascope’s Stiff Guidewire for use with Datascope IABs 5) K924607 - Arrow Fischell Corp.’s Super Arrow-Flex Percutaneous Shea…	Datascope Corp.	1990	—
*	K924607	Arrow Fischell Kink Resist Percut Sheath Intro Set Summary page 3 …rterial Cannula with Access Port. . . 3) K904476 - Datascope’s 5 to 9 Fr. Stepped Vessel Dilator 4) K904477 - Datascope’s Stiff Guidewire for use with Datascope IABs 5) K924607 - Arrow Fischell Corp.’s Super Arrow-Flex Percutaneous Sheath Introducer ) 6) K943896 - Datascope’s Staged Guide Wire for use w…	Arrow Intl., Inc.	1993	3
*	K943896	Guide Wire for the Use with Datascope Percor Stat-DL Iabs Summary page 3 …l Dilator 4) K904477 - Datascope’s Stiff Guidewire for use with Datascope IABs 5) K924607 - Arrow Fischell Corp.’s Super Arrow-Flex Percutaneous Sheath Introducer ) 6) K943896 - Datascope’s Staged Guide Wire for use with Datascope Percor STAT- DL IABs 7) K955785- C.R. Bard’s TS and Input Percutaneous A…	Datascope Corp.	1995	—
*	K955785	TS Percutaneous Arterial/Venus Catheter Intro Set Summary page 3 …7 - Arrow Fischell Corp.’s Super Arrow-Flex Percutaneous Sheath Introducer ) 6) K943896 - Datascope’s Staged Guide Wire for use with Datascope Percor STAT- DL IABs 7) K955785- C.R. Bard’s TS and Input Percutaneous Arterial/Venous Catheter Introducer Set All of the above referenced premarket notificatio…	C.R. Bard, Inc.	1996	4
*	K952430	Finesse Guidewire Coronary Summary page 3 …in: 1) K904477 - Datascope’s Stiff Guidewire for use with Datascope 1ABs 2) K943896 - Datascope’s Staged Guide Wire for use with Datascope Percor STAT- DL IABs ‘ 3) K952430 - Flexmedic’s Finesse guide wire for coronary use 4) K960563 - Scimed Sceptor ™ PTCA guide wire (platinum spring coil) ) 5) K9…	Flexmedics	1995	—
*	K960563	Scimed Sceptor & Sceptor Exchange Ptca Guide Wires Summary page 3 …tascope 1ABs 2) K943896 - Datascope’s Staged Guide Wire for use with Datascope Percor STAT- DL IABs ‘ 3) K952430 - Flexmedic’s Finesse guide wire for coronary use 4) K960563 - Scimed Sceptor ™ PTCA guide wire (platinum spring coil) ) 5) K961445 - Terumo’s Radiofocus® Glidewire® for coronary use (nick…	Scimed Life Systems, Inc.	1996	—
*	K961445	Radifocus Glidewire for Coronary Use with Platinum (or Gold) Coil Summary page 3 …tascope Percor STAT- DL IABs ‘ 3) K952430 - Flexmedic’s Finesse guide wire for coronary use 4) K960563 - Scimed Sceptor ™ PTCA guide wire (platinum spring coil) ) 5) K961445 - Terumo’s Radiofocus® Glidewire® for coronary use (nickel titanium : coil with platinum spring coil) Page 32 \…	Terumo Medical Corp.	1996	—
*	K970994	Core and Coil Assembly Guidewire Summary page 4 …re® for coronary use (nickel titanium : coil with platinum spring coil) Page 32 \ Summary of Safety & Effectiveness/Datascope 8Fr. Co-Lumen (CL) IAB 6) K970994 - Lake Region’s Nitinol core and platinum coil .014" - .045"guide wire for extravascular use. 7 K971322 - Lake Region’s Nitinol…	Lake Region Mfg., Inc.	1997	—

Also cleared against K790775: 1 other device →

What descends from it? (17)

See all 17

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K994157	Datascope's 8FR. Polymide 25CC,34CC and 40CC Iab and Accessories, Models 0684-00-0327…	Datascope Corp.	2000	15
K062582	Supracor Balloon Catheter	Abiomed, Inc.	2006	1

Has anything in its family been recalled? (5 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K063525Datascope Fiber Optic Pressure Sensor Intra-Aortic Balloon Catheter and CS300 Intra-Aortic Balloon Pump…Datascope Corp. · 2007 · 3 generations on · ◆ in the 2007 descendants bar of FIG. 11 Class I recall
K112372Cardiosave Hybrid Intra-Aortic Balloon PumpCardiac Assist, Maquet Cardiovascular, LLC · 2011 · 4 generations on · ◆ in the 2011 descendants bar of FIG. 110 Class I recalls
K181122CARDIOSAVE Intra-Aortic Balloon PumpDatascope Corp. · 2018 · 5 generations on · ◆ in the 2018 descendants bar of FIG. 127 Class I recalls
K151254CARDIOSAVE Hybrid Intra-Aortic Balloon PumpDatascope Corp. · 2015 · 5 generations on · ◆ in the 2015 descendants bar of FIG. 112 Class I recalls
K163542CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery Transport and Storage CaseDatascope Corp. · 2017 · 6 generations on · ◆ in the 2017 descendants bar of FIG. 17 Class I recalls

What does this lineage say?

The line of descent spans 8 years and passes through 3 companies; a new generation was cleared every 10 months on median.
3 of the 34 ancestors have a recall of any class.
Of its descendants, K994157 (Datascope Corp., 2000) has gone furthest, with 15 descendants of its own.
1 other device also cites its predicate K790775.

How does its category compare?

All DSP devices

DSP System, Balloon, Intra-Aortic And Control: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DSP

1in 2025

2007high 3 (2017) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DSP

140in 2019

2007high 140 (2019) · low 73 (2017)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DSP

4in 2025

2007high 33 (2022) · low 0 (2008)2026

Class I (47 since 2007) Class II/III not classified

Adverse event reports per year · DSP

7,422in 2025

2007high 7,422 (2025) · low 404 (2015)2025

MAUDE reports naming product code DSP, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	2	—	3	461
2008	0	—	0	617
2009	2	—	14	656
2010	0	—	8	1,019
2011	2	—	0	590
2012	2	—	3	490
2013	1	—	0	495
2014	0	—	1	1,738
2015	1	—	0	404
2016	0	—	9 (9)	419
2017	3	73	0	2,164
2018	1	—	2 (2)	3,331
2019	3	140	3	3,552
2020	2	—	0	3,393
2021	0	—	5 (3)	4,345
2022	0	—	33 (33)	5,113
2023	1	—	0	6,980
2024	0	—	1	7,317
2025	1	—	4	7,422
2026	0	—	0	—

What is it indicated for?

Refractory ventricular failure.

Cardiogenic shock.

Unstablei refractory angina.

Impending infarction.

Mechanical complications due to acute myocardial infarction, i.e., ventricular septal defect, mitral regurgitation or papillary muscle rupture.

Ischemia related intractable ventricular arrhythmias.

Cardiac support for high risk general surgical patients and coronary angiography/angioplasty patients.

Septic shock.

Weaning from cardiopulmonary bypass.

Intraoperative pulsatile flow generation.

Support for failed angioplasty and valvuloplasty.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K980385 · printed Nov 6, 2026

Cite this page

510(k) Report. “K980385: Datascope 8FR. CO-Lumen 34 and 40CC Intra-Aortic Balloon Catheters for Optional Sheathless Insertion with Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K980385

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026