510(k) Report

510(k) · Cleared

Cleared

Datascope Percor Stat-DL 9.5 FR. 25, 34 and 40CC Intra-Aoric Balloons with Alternate B Membrane for Optional Sheathles

K980780510(k) TraditionalCleared May 29, 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 29, 1998 as substantially equivalent to K905056 (Datascope Corp., 1991) and 9 other predicates after an 88-day review. Its family tree reaches back 2 generations to 1991. 5 of the 32 devices in its family, counting itself, have a Class I recall. 16 later devices descend from it.

Decided
May 29, 1998
Review
88 days
Class
Class II
Product code
DSP
Recalls
None
Predicates
11

Its longest line of descent runs back 2 generations to K905056 (1991). 15 ancestors in all, the oldest K790775 (1979). 16 later devices descend from it, 2 citing it directly. 5 of the 32 devices in this family, counting this one, have a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 1997: 2 other ancestors1996: 2 other ancestors1995: 3 other ancestors1994: 2 other ancestors1991: 1 other ancestor1989: 1 other ancestor1993: 1 other ancestor1979: 1 other ancestor2002: 1 descendant cleared2000: 1 descendant cleared2001: 1 descendant cleared2004: 1 descendant cleared2003: 1 descendant cleared2009: 2 descendants cleared2007: 1 descendant cleared, 1 with a Class I recall12017: 2 descendants cleared, 1 with a Class I recall12011: 2 descendants cleared, 1 with a Class I recall12013: 1 descendant cleared2012: 1 descendant cleared2018: 1 descendant cleared, 1 with a Class I recall12015: 1 descendant cleared, 1 with a Class I recall1K905056 · Percor Stat-DL 9.5 FR W/Opt Insert W/O Intro Sheat · Datascope Corp. · 1991K960166 · Percor Stat-DL 9.5 FR. 34 & 40CC · Datascope Corp. · 199619801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 8 other ancestors2 generations back: 5 other ancestors 1 generation forward: 2 descendants2 generations forward: 1 descendant3 generations forward: 4 descendants, 1 with a Class I recall14 generations forward: 5 descendants, 1 with a Class I recall15 generations forward: 3 descendants, 2 with a Class I recall26 generations forward: 1 descendant, 1 with a Class I recall1 K960166 · Percor Stat-DL 9.5 FR. 34 & 40CC · Datascope Corp. · 1996K905056 · Percor Stat-DL 9.5 FR W/Opt Insert W/O Intro Sheat · Datascope Corp. · 19910+5
  1. Root · 2 generations backK905056 Percor Stat-DL 9.5 FR W/Opt Insert W/O Intro SheatDatascope Corp. · 1991
  2. 1 generation backK960166 Percor Stat-DL 9.5 FR. 34 & 40CCDatascope Corp. · 1996
  3. This deviceK980780 Datascope Percor Stat-DL 9.5 FR. 25, 34 and 40CC Intra-Aoric…Datascope Corp. · 1998
  4. Descendant · cites it directly · 15 of its ownK994157 Datascope's 8FR. Polymide 25CC,34CC and 40CC Iab and Accessories…Datascope Corp. · 2000
  5. Descendant · 2 generations on · 14 of its ownK013326 Modification to: Datascope 8FR. Polyimide Alt B Iab, 25CC, 34CC…Datascope Corp. · 2001
  6. Descendant · 3 generations on · 12 of its ownK031569 Datascope CA 40 8FR. Iabs, Model 0684-00-04XXDatascope Corp. · 2003
  7. Descendant · 3 generations on · 11 of its ownK041281 Datascope 7.5FR. Iab Catheter and AccessoriesDatascope Corp. · 2004 · Recalled
  8. 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 16 descendants. See all descendants

Descendants cleared per year

2000: 12001: 12002: 12003: 12004: 12007: 12009: 22011: 22012: 12013: 12015: 12017: 22018: 1
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 16 · 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

GenerationNumberDeviceApplicantDecidedRecalls
−2K905056Percor Stat-DL 9.5 FR W/Opt Insert W/O Intro SheatDatascope Corp.1991—
−1K960166Percor Stat-DL 9.5 FR. 34 & 40CCDatascope Corp.1996—
0 (this device)K980780Datascope Percor Stat-DL 9.5 FR. 25, 34 and 40CC Intra-Aoric Balloons with…Datascope Corp.1998—
+1K994157Datascope's 8FR. Polymide 25CC,34CC and 40CC Iab and Accessories, Models…Datascope Corp.2000—
+2K013326Modification to: Datascope 8FR. Polyimide Alt B Iab, 25CC, 34CC, 40CC…Datascope Corp.2001—
+3K031569Datascope CA 40 8FR. Iabs, Model 0684-00-04XXDatascope Corp.2003—
+3K041281Datascope 7.5FR. Iab Catheter and AccessoriesDatascope Corp.20047
+3K063525Datascope Fiber Optic Pressure Sensor Intra-Aortic Balloon Catheter and CS300…Datascope Corp.2007Class I

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197910
198910
199110
199310
199420
199530
199620
199720

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200010
200110
200210
200310
200410
200711
200920
201121
201210
201310
201511
201721
201811
FIG. 1 — Lineage of K980780, 1991–2018Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K250542 AC3™ Range™ Intra-Aortic Balloon Pumpscore 11.2 · 8 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (11)

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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

TypeNumberDeviceApplicantDecidedRecalls
*K905056Percor Stat-DL 9.5 FR W/Opt Insert W/O Intro Sheat
Summary page 1
…535 Product Code: 74DSP PREDICATE DEVICE INFORMATION Datascope’s Percor STAT-DL® Intra-Aortic Balloon is substantially equivalent to the following marketed devices: - K905056- Datascope Percor STAT-DL 9.5Fr. with Optional Insertion without an Introducer Sheath - K910997- Datascope Percor STAT IABs with…
Datascope Corp.1991—
*K910997Datascope Percor Stat Intra-Aortic Balloon
Summary page 1
…alloon is substantially equivalent to the following marketed devices: - K905056- Datascope Percor STAT-DL 9.5Fr. with Optional Insertion without an Introducer Sheath - K910997- Datascope Percor STAT IABs with Alternate Coating - K940178- Datascope Percor STAT-DL®9.5Fr. 34 & 40cc IABs - K940231- Datasco…
Datascope Corp.1991—
*K940178Percor Stat-DL 9.5 FR.34CC & 40CC /Percor Stat-DL 10.5 FR.40CC & 50CC Intra-Aortic…
Summary page 1
…evices: - K905056- Datascope Percor STAT-DL 9.5Fr. with Optional Insertion without an Introducer Sheath - K910997- Datascope Percor STAT IABs with Alternate Coating - K940178- Datascope Percor STAT-DL®9.5Fr. 34 & 40cc IABs - K940231- Datascope Percor STAT-DL 9.5Fr. 40cc IAB Page 25 Sum…
Datascope Corp.1994—
*K940231Intra-Aortic Balloon for Optional Sheathless Insertion
Summary page 1
…tional Insertion without an Introducer Sheath - K910997- Datascope Percor STAT IABs with Alternate Coating - K940178- Datascope Percor STAT-DL®9.5Fr. 34 & 40cc IABs - K940231- Datascope Percor STAT-DL 9.5Fr. 40cc IAB Page 25 Summary of Safety & Effectiveness/Datascope Percor STAT-DL®9.5…
Datascope Corp.1994—
Kept off the family treeK943846Datascope’s Staged Guidewire
Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree
Summary page 2
…40cc IABs - K940231- Datascope Percor STAT-DL 9.5Fr. 40cc IAB Page 25 Summary of Safety & Effectiveness/Datascope Percor STAT-DL®9.5 Fr. IAB Page 2 - K943846 - Datascope’s Staged Guidewire - K960166- Datascope Percor STAT-DL 9.5Fr. 34 & 40cc IABs for Optional Sheathless Insertion - K9…
*K960166Percor Stat-DL 9.5 FR. 34 & 40CC
Summary page 2
…AT-DL 9.5Fr. 40cc IAB Page 25 Summary of Safety & Effectiveness/Datascope Percor STAT-DL®9.5 Fr. IAB Page 2 - K943846 - Datascope’s Staged Guidewire - K960166- Datascope Percor STAT-DL 9.5Fr. 34 & 40cc IABs for Optional Sheathless Insertion - K964987- Datascope Percor STAT DL 9.5Fr. 25…
Datascope Corp.1996—
*K964987Datascope Percor Stat - DL 9.5 FR. 25 and 40CC Intra-Aortic Balloon for Optional…
Summary page 2
…rcor STAT-DL®9.5 Fr. IAB Page 2 - K943846 - Datascope’s Staged Guidewire - K960166- Datascope Percor STAT-DL 9.5Fr. 34 & 40cc IABs for Optional Sheathless Insertion - K964987- Datascope Percor STAT DL 9.5Fr. 25 & 40cc IABs for Optional Sheathless Insertion - K960713 - Arrow International 8 Fr. 40 Narro…
Datascope Corp.19971
*K9607138 FR.-40CC Arrow Flex Intra-Aortic Balloon Catheter with Blue Flex Tip, Product Number…
Summary page 2
…pe Percor STAT-DL 9.5Fr. 34 & 40cc IABs for Optional Sheathless Insertion - K964987- Datascope Percor STAT DL 9.5Fr. 25 & 40cc IABs for Optional Sheathless Insertion - K960713 - Arrow International 8 Fr. 40 NarrowFlex™ IAB - K892799 - Arrow International 8 Fr. 30cc IAB - K945230 - Arrow International Kin…
Arrow Intl., Inc.1996—
*K8927998 FR Percutan Double Lumen Intra-Aortic Balloon
Summary page 2
…thless Insertion - K964987- Datascope Percor STAT DL 9.5Fr. 25 & 40cc IABs for Optional Sheathless Insertion - K960713 - Arrow International 8 Fr. 40 NarrowFlex™ IAB - K892799 - Arrow International 8 Fr. 30cc IAB - K945230 - Arrow International Kink Resistant 9.5 Fr. Flexi-Cath IAB - K963104 - Arrow Int…
Kontron Instruments, Inc.1989—
*K945230Arrow Kink Resistant Flexi-Cath Intra-Aortic Balloon
Summary page 2
…TAT DL 9.5Fr. 25 & 40cc IABs for Optional Sheathless Insertion - K960713 - Arrow International 8 Fr. 40 NarrowFlex™ IAB - K892799 - Arrow International 8 Fr. 30cc IAB - K945230 - Arrow International Kink Resistant 9.5 Fr. Flexi-Cath IAB - K963104 - Arrow International 9.5 Fr. Flexi-Cath IAB D. DEVIC SCR…
Arrow Intl., Inc.1995—
*K9631049.5 FR.- Flexi-Cath Intra-Aortic and Control System
Summary page 2
…13 - Arrow International 8 Fr. 40 NarrowFlex™ IAB - K892799 - Arrow International 8 Fr. 30cc IAB - K945230 - Arrow International Kink Resistant 9.5 Fr. Flexi-Cath IAB - K963104 - Arrow International 9.5 Fr. Flexi-Cath IAB D. DEVIC SCRIPTION/INTENDED USE The intra-aortic balloon is placed in the descendin…
Arrow Intl., Inc.1997—

Also cleared against K905056: 2 other devices →

What descends from it? (16)

See all 16

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

NumberDeviceApplicantDecidedDescendants
K994157Datascope's 8FR. Polymide 25CC,34CC and 40CC Iab and Accessories, Models 0684-00-0327…Datascope Corp.200015
K020257Datascope's 8FR. Alt B Iab; Datascope's Profile 8FR. Alt B Iab; Datascope's True…Datascope Corp.20020

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 7 years and passes through 1 company; a new generation was cleared every 4.9 years on median.
  • 1 of the 15 ancestors has a recall of any class.
  • Of its descendants, K994157 (Datascope Corp., 2000) has gone furthest, with 15 descendants of its own.
  • 2 other devices also cite its predicate K905056.

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

2007: 22009: 22011: 22012: 22013: 12015: 12017: 32018: 12019: 32020: 22023: 12025: 1
2007high 3 (2017) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DSP

140in 2019

2017: 73 days median2019: 140 days median
2007high 140 (2019) · low 73 (2017)2026

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

Recalls per year · DSP

4in 2025

2007: 32009: 142010: 82012: 32014: 12016: 9, 9 Class I2018: 2, 2 Class I2019: 32021: 5, 3 Class I2022: 33, 33 Class I2024: 12025: 4
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

2007: 4612008: 6172009: 6562010: 1,0192011: 5902012: 4902013: 4952014: 1,7382015: 4042016: 4192017: 2,1642018: 3,3312019: 3,5522020: 3,3932021: 4,3452022: 5,1132023: 6,9802024: 7,3172025: 7,422
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—3461
20080—0617
20092—14656
20100—81,019
20112—0590
20122—3490
20131—0495
20140—11,738
20151—0404
20160—9 (9)419
201737302,164
20181—2 (2)3,331
2019314033,552
20202—03,393
20210—5 (3)4,345
20220—33 (33)5,113
20231—06,980
20240—17,317
20251—47,422
20260—0—

What is it indicated for?

Refractory ventricular failure.

Cardiogenic shock.

Unstable 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.

Also cleared against K905056

2 other devices cite the same predicate.

  • K980385Datascope 8FR. CO-Lumen 34 and 40CC Intra-Aortic Balloon Catheters for Optional Sheathless Insertion with…Datascope Corp. · 1998
  • K960166Percor Stat-DL 9.5 FR. 34 & 40CCDatascope Corp. · 1996

More from Datascope Corp.

149 FDA decisions under this applicant name. See the company

  • K190884TigerPaw Pro Left Atrial Appendage Occlusion Fastener And Delivery ToolDatascope Corp. · 2019
  • K181122CARDIOSAVE Intra-Aortic Balloon PumpDatascope Corp. · 201827 Class I recalls
  • K172305CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon PumpDatascope Corp. · 20172 recalls
  • K163542CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery Transport and Storage CaseDatascope Corp. · 20177 Class I recalls
  • K151254CARDIOSAVE Hybrid Intra-Aortic Balloon PumpDatascope Corp. · 201512 Class I recalls

Recent decisions in DSP

The DSP category page

  • K250542AC3™ Range™ Intra-Aortic Balloon PumpArrow International, LLC · 2025
  • K232343AC3™ Series IABPArrow International, LLC · 2023
  • K201112AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABPArrow International, Inc. · 202011 Class I recalls
  • K200634Arrow FiberOptix Intra-Aortic Balloon Catheter KitArrow International, Inc. · 20201 Class I recall
  • K192238AC3 Series Intra-Aortic Balloon Pump (IABP)Arrow International, Teleflex · 2019

https://510kreport.com/device/K980780 · printed Nov 5, 2026

Cite this page

510(k) Report. “K980780: Datascope Percor Stat-DL 9.5 FR. 25, 34 and 40CC Intra-Aoric Balloons with Alternate B Membrane for Optional Sheathles.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K980780

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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