510(k) Report

510(k) · Cleared

Recalled · Class II · 2024

Datascope 7.5FR. Iab Catheter and Accessories

K041281510(k) SpecialCleared Jun 7, 200425-day reviewClass II21 CFR 870.3535Recalls 7

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 Jun 7, 2004 as substantially equivalent to K031569 (Datascope Corp., 2003) and 2 other predicates after a 25-day review. Its family tree reaches back 7 generations to 1990. 5 of the 56 devices in its family, counting itself, have a Class I recall. 11 later devices descend from it. It has been recalled 7 times.

Decided
Jun 7, 2004
Review
25 days
Class
Class II
Product code
DSP
Recalls
7
Predicates
3

Its longest line of descent runs back 7 generations to K892222 (1990). 44 ancestors in all, the oldest K790775 (1979). 11 later devices descend from it, 3 citing it directly. 5 of the 56 devices in this family, counting this one, have a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2000: 2 other ancestors1995: 8 other ancestors1998: 1 other ancestor1997: 4 other ancestors1996: 7 other ancestors1994: 3 other ancestors1993: 4 other ancestors1991: 3 other ancestors1990: 2 other ancestors1989: 1 other ancestor1982: 1 other ancestor1979: 1 other ancestor2009: 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 recall1K892222 · 9.5F Percu Double Lumen Intra-Aortic Balloon · Kontron Instruments, Inc. · 1990K963187 · Modified Labeling of Cardiac Assist Intra-Aortic Balloon Catheters: Model 930 - 940, 30 - 40 CC Sensation and Nicath 30C · Boston Scientific Corp · 1996K972113 · 30 CC and 40 CC Sub-9 Nitinol and 30 and 40 CC Sub-9 Stainless Steel · Boston Scientific Corp · 1997K980385 · Datascope 8FR. CO-Lumen 34 and 40CC Intra-Aortic Balloon Catheters for Optional Sheathless Insertion with Accessories · Datascope Corp. · 1998K994157 · Datascope's 8FR. Polymide 25CC,34CC and 40CC Iab and Accessories, Models 0684-00-0327, 06844-00-0328, 0684-00-0329 · Datascope Corp. · 2000K013326 · Modification to: Datascope 8FR. Polyimide Alt B Iab, 25CC, 34CC, 40CC, Datascope Insertion Kit for 8 FR, Polyimide Alt B · Datascope Corp. · 2001K031569 · Datascope CA 40 8FR. Iabs, Model 0684-00-04XX · Datascope Corp. · 200319801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 2 other ancestors3 generations back: 1 other ancestor4 generations back: 25 other ancestors5 generations back: 8 other ancestors 1 generation forward: 3 descendants, 1 with a Class I recall12 generations forward: 4 descendants, 1 with a Class I recall13 generations forward: 3 descendants, 2 with a Class I recall24 generations forward: 1 descendant, 1 with a Class I recall1 K031569 · Datascope CA 40 8FR. Iabs, Model 0684-00-04XX · Datascope Corp. · 2003K013326 · Modification to: Datascope 8FR. Polyimide Alt B Iab, 25CC, 34CC, 40CC, Datascope Insertion Kit for 8 FR, Polyimide Alt B · Datascope Corp. · 2001K994157 · Datascope's 8FR. Polymide 25CC,34CC and 40CC Iab and Accessories, Models 0684-00-0327, 06844-00-0328, 0684-00-0329 · Datascope Corp. · 2000K980385 · Datascope 8FR. CO-Lumen 34 and 40CC Intra-Aortic Balloon Catheters for Optional Sheathless Insertion with Accessories · Datascope Corp. · 1998K972113 · 30 CC and 40 CC Sub-9 Nitinol and 30 and 40 CC Sub-9 Stainless Steel · Boston Scientific Corp · 1997K963187 · Modified Labeling of Cardiac Assist Intra-Aortic Balloon Catheters: Model 930 - 940, 30 - 40 CC Sensation and Nicath 30C · Boston Scientific Corp · 1996K892222 · 9.5F Percu Double Lumen Intra-Aortic Balloon · Kontron Instruments, Inc. · 1990−50
  1. Root · 7 generations backK892222 9.5F Percu Double Lumen Intra-Aortic BalloonKontron Instruments, Inc. · 1990
  2. 6 generations backK963187 Modified Labeling of Cardiac Assist Intra-Aortic Balloon Catheters…Boston Scientific Corp · 1996
  3. 5 generations backK972113 30 CC and 40 CC Sub-9 Nitinol and 30 and 40 CC Sub-9 Stainless SteelBoston Scientific Corp · 1997
  4. 4 generations backK980385 Datascope 8FR. CO-Lumen 34 and 40CC Intra-Aortic Balloon Catheters…Datascope Corp. · 1998
  5. 3 generations backK994157 Datascope's 8FR. Polymide 25CC,34CC and 40CC Iab and Accessories…Datascope Corp. · 2000
  6. 2 generations backK013326 Modification to: Datascope 8FR. Polyimide Alt B Iab, 25CC, 34CC…Datascope Corp. · 2001
  7. 1 generation backK031569 Datascope CA 40 8FR. Iabs, Model 0684-00-04XXDatascope Corp. · 2003
  8. This deviceK041281 Datascope 7.5FR. Iab Catheter and AccessoriesDatascope Corp. · 2004
  9. Descendant · cites it directly · 8 of its ownK063525 Datascope Fiber Optic Pressure Sensor Intra-Aortic Balloon Catheter…Datascope Corp. · 2007 · Recalled (Class I)
  10. Descendant · 2 generations on · 3 of its ownK112372 Cardiosave Hybrid Intra-Aortic Balloon PumpCardiac Assist, Maquet Cardiovascular, LLC · 2011 · Recalled (Class I)
  11. Descendant · cites it directly · 3 of its ownK091449 Datascope's 8FR. 50CC Intra-Aortic Balloon Catheter and Accessories…Datascope Corp., Cardiac Assist Division · 2009
  12. Descendant · 2 generations on · 2 of its ownK112327 Sensation (TM) Plus 8FR. 50CC Intra-Aortic Balloon Catheter and…Cardiac Assist, Maquet Cardiovascular, LLC · 2011 · Recalled
  13. Descendant · 3 generations on · 1 of its ownK151254 CARDIOSAVE Hybrid Intra-Aortic Balloon PumpDatascope Corp. · 2015 · Recalled (Class I)

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2007: 12009: 22011: 22012: 12013: 12015: 12017: 22018: 1
2007high 2 (2009) · low 0 (2008)2026

Class I recalls in this family

  • K063525 Datascope Fiber Optic Pressure Sensor…cites it directly · 2007
  • K112372 Cardiosave Hybrid Intra-Aortic Balloon Pump2 generations on · 2011
  • K181122 CARDIOSAVE Intra-Aortic Balloon Pump3 generations on · 2018
  • K151254 CARDIOSAVE Hybrid Intra-Aortic Balloon Pump3 generations on · 2015

Most influential descendants

Showing 5 of 11 · See all
  • K063525Datascope Fiber Optic Pressure Sensor Intra-Aortic Balloon Catheter and CS300…Datascope Corp. · 2007 · cites it directly8descendants
  • K112372Cardiosave Hybrid Intra-Aortic Balloon PumpCardiac Assist, Maquet Cardiovascular, LLC · 2011 · 2 generations on3descendants
  • K091449Datascope's 8FR. 50CC Intra-Aortic Balloon Catheter and Accessories, Models…Datascope Corp., Cardiac Assist Division · 2009 · cites it directly3descendants
  • K112327Sensation (TM) Plus 8FR. 50CC Intra-Aortic Balloon Catheter and AccessoriesCardiac Assist, Maquet Cardiovascular, LLC · 2011 · 2 generations on2descendants
  • K151254CARDIOSAVE Hybrid Intra-Aortic Balloon PumpDatascope Corp. · 2015 · 3 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−7K8922229.5F Percu Double Lumen Intra-Aortic BalloonKontron Instruments, Inc.1990—
−6K963187Modified Labeling of Cardiac Assist Intra-Aortic Balloon Catheters: Model 930…Boston Scientific Corp1996—
−5K97211330 CC and 40 CC Sub-9 Nitinol and 30 and 40 CC Sub-9 Stainless SteelBoston Scientific Corp1997—
−4K980385Datascope 8FR. CO-Lumen 34 and 40CC Intra-Aortic Balloon Catheters for…Datascope Corp.1998—
−3K994157Datascope'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—
−1K031569Datascope CA 40 8FR. Iabs, Model 0684-00-04XXDatascope Corp.2003—
0 (this device)K041281Datascope 7.5FR. Iab Catheter and AccessoriesDatascope Corp.2004—
+1K063525Datascope Fiber Optic Pressure Sensor Intra-Aortic Balloon Catheter and CS300…Datascope Corp.2007Class I
+2K112372Cardiosave Hybrid Intra-Aortic Balloon PumpCardiac Assist, Maquet Cardiovascular, LLC2011Class I
+1K091449Datascope's 8FR. 50CC Intra-Aortic Balloon Catheter and Accessories, Models…Datascope Corp., Cardiac Assist Division2009—
+2K112327Sensation (TM) Plus 8FR. 50CC Intra-Aortic Balloon Catheter and AccessoriesCardiac Assist, Maquet Cardiovascular, LLC20111
+3K151254CARDIOSAVE Hybrid Intra-Aortic Balloon PumpDatascope Corp.2015Class I

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197910
198210
198910
199020
199130
199340
199430
199580
199670
199740
199810
200020

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200711
200920
201121
201210
201310
201511
201721
201811
FIG. 1 — Lineage of K041281, 1990–2018Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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? (3)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K031569Datascope CA 40 8FR. Iabs, Model 0684-00-04XX
Summary page 1
…s are substantially equivalent to the following marketed devices: K031569 - Datascope's Blow-Molded 8Fr. JAB, S/E 6/10/03 K013326 - Datascope's Fidelit…
Datascope Corp.2003—
*K013326Modification to: Datascope 8FR. Polyimide Alt B Iab, 25CC, 34CC, 40CC, Datascope…
Summary page 1
…devices: K031569 - Datascope's Blow-Molded 8Fr. JAB, S/E 6/10/03 K013326 - Datascope's Fidelity 8Fr. IAB, S/E 11/02/01 K002365 - Datascope's Reinforce…
Datascope Corp.2001—
*K002365Datascope Reinforced Percutaneous Catheter Introducer Set
Summary page 1
…S/E 6/10/03 K013326 - Datascope's Fidelity 8Fr. IAB, S/E 11/02/01 K002365 - Datascope's Reinforced Catheter Introducer Set, S/E 8/25/00 D. DEVICE DESCRIPTION/INTENDED USE Datascop…
Datascope Corp.20001

Also cleared against K031569: 2 other devices →

What descends from it? (11)

See all 11

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

NumberDeviceApplicantDecidedDescendants
K063525Datascope Fiber Optic Pressure Sensor Intra-Aortic Balloon Catheter and CS300… Class IDatascope Corp.20078
K091449Datascope's 8FR. 50CC Intra-Aortic Balloon Catheter and Accessories, Models…Datascope Corp., Cardiac Assist Division20093
K082746Ultra Iabp Catheter Kit, Models IMU7F-40, IMU7F-35, IMU7F-30, IMU7F-25, IMU7F-20Insightra Medical, Inc.20090

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

Recalls of this device

DateClassRecallRoot causeReason
Sep 17, 2024Class IIZ-0311-2025Error in labelingThere is discrepant labeling on the inner and outer packaging of the device.
Jun 23, 2023Class IIZ-2223-2023Under Investigation by firmDuring IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body of the introducer dilator housed within the sheath. Risks to health include damage to the femoral artery, descending aorta, or embolization…
Aug 5, 2022Class IIZ-0131-2023Labeling Change ControlThe balloon volume is incorrectly described as 34cc instead of 40cc on one of the three internal labels enclosed for hospital use. A labelling error may result in user confusion and/or delay in initiating therapy. Therapy delays may…
Jul 27, 2020Class IIZ-2839-2020Process change controlPotential Endotoxin Contamination
Jul 27, 2020Class IIZ-2840-2020Process change controlPotential Endotoxin Contamination
Jul 27, 2020Class IIZ-2838-2020Process change controlPotential Endotoxin Contamination
Aug 11, 2014Class IIIZ-2568-2014Labeling False and MisleadingDuring label reconciliation a duplicate serial number label was detected to be printed for the LINEAR 7.5 FR 40 cc Intra-Aortic Balloon Catheter.

The 5 latest of 7 recalls; the web page lists all.

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 · Cites it directly · ◆ in the 2007 descendants bar of FIG. 11 Class I recall
  • K112372Cardiosave Hybrid Intra-Aortic Balloon PumpCardiac Assist, Maquet Cardiovascular, LLC · 2011 · 2 generations on · ◆ in the 2011 descendants bar of FIG. 110 Class I recalls
  • K181122CARDIOSAVE Intra-Aortic Balloon PumpDatascope Corp. · 2018 · 3 generations on · ◆ in the 2018 descendants bar of FIG. 127 Class I recalls
  • K151254CARDIOSAVE Hybrid Intra-Aortic Balloon PumpDatascope Corp. · 2015 · 3 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 · 4 generations on · ◆ in the 2017 descendants bar of FIG. 17 Class I recalls

What does this lineage say?

  • The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 1.6 years on median.
  • 4 of the 44 ancestors have a recall of any class.
  • Of its descendants, K063525 (Datascope Corp., 2007) has gone furthest, with 8 descendants of its own.
  • 2 other devices also cite its predicate K031569.

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?

Datascope's 7.5Fr. Intra-Aortic Balloon Catheters and Accessories have the following indications for use: * Refractory unstable angina * Impending infarction * Acute MI * Refractory ventricular failure * Complications of acute MI (i.e. Acute MR or VSD, or papillary muscle rupture) - Cardiogenic shock Support for diagnostic, percutaneous revascularization, and interventional procedures. Ischemia related intractable ventricular arrhythmias Septic shock…

Read the full statement (107 words)

Datascope's 7.5Fr. Intra-Aortic Balloon Catheters and Accessories have the following indications for use:

* Refractory unstable angina

* Impending infarction

* Acute MI

* Refractory ventricular failure

* Complications of acute MI (i.e. Acute MR or VSD, or papillary muscle rupture)

- Cardiogenic shock

Support for diagnostic, percutaneous revascularization, and interventional procedures.

Ischemia related intractable ventricular arrhythmias

Septic shock

Intraoperative pulsatile flow generation

* Weaning from bypass

* Cardiac support for non-cardiac surgery

* Prophylactic support in preparation for cardiac surgery

* Post surgical myocardial dysfunction/low cardiac output syndrome

* Myocardial contusion

* Mechanical bridge to other assist devices

* Cardiac support following correction of anatomical defects

Indications for use as stated in the FDA summary.

Also cleared against K031569

2 other devices cite the same predicate.

  • K091449Datascope's 8FR. 50CC Intra-Aortic Balloon Catheter and Accessories, Models 0684,00-0498-01, 02Datascope Corp., Cardiac Assist Division · 2009
  • K063525Datascope Fiber Optic Pressure Sensor Intra-Aortic Balloon Catheter and CS300 Intra-Aortic Balloon Pump…Datascope Corp. · 20071 Class I recall

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/K041281 · printed Nov 6, 2026

Cite this page

510(k) Report. “K041281: Datascope 7.5FR. Iab Catheter and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041281

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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