510(k) Report

510(k) · Cleared

Recalled · 2003

Datascope Percor Stat - DL 9.5 FR. 25 and 40CC Intra-Aortic Balloon for Optional Sheathless Insertion and Percor Stat -0

K964987510(k) TraditionalCleared Mar 17, 199794-day reviewClass II21 CFR 870.3535Recalls 1

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 Mar 17, 1997 as substantially equivalent to K940231 (Datascope Corp., 1994) and 6 other predicates after a 94-day review. Its family tree reaches back 1 generation to 1979. 5 of the 28 devices in its family, counting itself, have a Class I recall. 20 later devices descend from it. It has been recalled once.

Decided
Mar 17, 1997
Review
94 days
Class
Class II
Product code
DSP
Recalls
1
Predicates
7

Its longest line of descent runs back 1 generation to K790775 (1979). 7 ancestors in all. 20 later devices descend from it, 4 citing it directly. 5 of the 28 devices in this family, counting this one, have a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 1996: 1 other ancestor1995: 2 other ancestors1994: 2 other ancestors1993: 1 other ancestor1998: 2 descendants cleared2002: 1 descendant cleared1997: 1 descendant cleared2000: 1 descendant cleared2006: 1 descendant cleared2009: 2 descendants cleared2001: 1 descendant cleared2004: 1 descendant cleared2003: 1 descendant 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 recall1K790775 · Intra-Aortic Balloon, Type S · Datascope Corp. · 197919801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 6 other ancestors 1 generation forward: 4 descendants2 generations forward: 2 descendants3 generations forward: 2 descendants4 generations forward: 4 descendants, 1 with a Class I recall15 generations forward: 4 descendants, 1 with a Class I recall16 generations forward: 3 descendants, 2 with a Class I recall27 generations forward: 1 descendant, 1 with a Class I recall1 K790775 · Intra-Aortic Balloon, Type S · Datascope Corp. · 19790+5
  1. Root · 1 generation backK790775 Intra-Aortic Balloon, Type SDatascope Corp. · 1979
  2. This deviceK964987 Datascope Percor Stat - DL 9.5 FR. 25 and 40CC Intra-Aortic Balloon…Datascope Corp. · 1997
  3. Descendant · cites it directly · 17 of its ownK980385 Datascope 8FR. CO-Lumen 34 and 40CC Intra-Aortic Balloon Catheters…Datascope Corp. · 1998
  4. Descendant · cites it directly · 16 of its ownK980780 Datascope Percor Stat-DL 9.5 FR. 25, 34 and 40CC Intra-Aoric…Datascope Corp. · 1998
  5. Descendant · 2 generations on · 15 of its ownK994157 Datascope's 8FR. Polymide 25CC,34CC and 40CC Iab and Accessories…Datascope Corp. · 2000
  6. Descendant · 3 generations on · 14 of its ownK013326 Modification to: Datascope 8FR. Polyimide Alt B Iab, 25CC, 34CC…Datascope Corp. · 2001
  7. Descendant · 4 generations on · 12 of its ownK031569 Datascope CA 40 8FR. Iabs, Model 0684-00-04XXDatascope Corp. · 2003

Showing 5 of 20 descendants. See all descendants

Descendants cleared per year

1997: 11998: 22000: 12001: 12002: 12003: 12004: 12006: 12007: 12009: 22011: 22012: 12013: 12015: 12017: 22018: 1
1997high 2 (1998) · low 0 (1999)2026

Class I recalls in this family

  • K063525 Datascope Fiber Optic Pressure Sensor…4 generations on · 2007
  • K112372 Cardiosave Hybrid Intra-Aortic Balloon Pump5 generations on · 2011
  • K181122 CARDIOSAVE Intra-Aortic Balloon Pump6 generations on · 2018
  • K151254 CARDIOSAVE Hybrid Intra-Aortic Balloon Pump6 generations on · 2015

Most influential descendants

Showing 5 of 20 · See all
  • K980385Datascope 8FR. CO-Lumen 34 and 40CC Intra-Aortic Balloon Catheters for Optional…Datascope Corp. · 1998 · cites it directly17descendants
  • K980780Datascope Percor Stat-DL 9.5 FR. 25, 34 and 40CC Intra-Aoric Balloons with Alternate B…Datascope Corp. · 1998 · cites it directly16descendants
  • K994157Datascope's 8FR. Polymide 25CC,34CC and 40CC Iab and Accessories, Models 0684-00-0327…Datascope Corp. · 2000 · 2 generations on15descendants
  • K013326Modification to: Datascope 8FR. Polyimide Alt B Iab, 25CC, 34CC, 40CC, Datascope…Datascope Corp. · 2001 · 3 generations on14descendants
  • K031569Datascope CA 40 8FR. Iabs, Model 0684-00-04XXDatascope Corp. · 2003 · 4 generations on12descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K790775Intra-Aortic Balloon, Type SDatascope Corp.1979—
0 (this device)K964987Datascope Percor Stat - DL 9.5 FR. 25 and 40CC Intra-Aortic Balloon for…Datascope Corp.1997—
+1K980385Datascope 8FR. CO-Lumen 34 and 40CC Intra-Aortic Balloon Catheters for…Datascope Corp.1998—
+1K980780Datascope Percor Stat-DL 9.5 FR. 25, 34 and 40CC Intra-Aoric Balloons with…Datascope Corp.1998—
+2K994157Datascope's 8FR. Polymide 25CC,34CC and 40CC Iab and Accessories, Models…Datascope Corp.2000—
+3K013326Modification to: Datascope 8FR. Polyimide Alt B Iab, 25CC, 34CC, 40CC…Datascope Corp.2001—
+4K031569Datascope CA 40 8FR. Iabs, Model 0684-00-04XXDatascope Corp.2003—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199310
199420
199520
199610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
199820
200010
200110
200210
200310
200410
200610
200711
200920
201121
201210
201310
201511
201721
201811
FIG. 1 — Lineage of K964987, 1979–2018Source: 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? (7)

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
*K940231Intra-Aortic Balloon for Optional Sheathless Insertion
Summary page 1
…e’s Percor STAT-DL® Intra-Aortic Balloon is substantially equivalent to the following marketed devices: - Datascope Percor STAT-DL®9.5Fr.&10.5Fr. Intra-Aortic Balloons, K940231 & K940178. - K905663 - Pediatric IAB - K790775 - Datascope Type “S” IAB - K952221- 30cc/40cc Sensation™ IAB; Model 930/940 IAB…
Datascope Corp.1994—
*K940178Percor Stat-DL 9.5 FR.34CC & 40CC /Percor Stat-DL 10.5 FR.40CC & 50CC Intra-Aortic…
Summary page 1
…STAT-DL® Intra-Aortic Balloon is substantially equivalent to the following marketed devices: - Datascope Percor STAT-DL®9.5Fr.&10.5Fr. Intra-Aortic Balloons, K940231 & K940178. - K905663 - Pediatric IAB - K790775 - Datascope Type “S” IAB - K952221- 30cc/40cc Sensation™ IAB; Model 930/940 IAB’s (Boston…
Datascope Corp.1994—
*K905663Pediatric Intra-Aortic Balloon Catheters
Summary page 1
…tra-Aortic Balloon is substantially equivalent to the following marketed devices: - Datascope Percor STAT-DL®9.5Fr.&10.5Fr. Intra-Aortic Balloons, K940231 & K940178. - K905663 - Pediatric IAB - K790775 - Datascope Type “S” IAB - K952221- 30cc/40cc Sensation™ IAB; Model 930/940 IAB’s (Boston Scientific…
Datascope Corp.1993—
*K790775Intra-Aortic Balloon, Type S
Summary page 1
…antially equivalent to the following marketed devices: - Datascope Percor STAT-DL®9.5Fr.&10.5Fr. Intra-Aortic Balloons, K940231 & K940178. - K905663 - Pediatric IAB - K790775 - Datascope Type “S” IAB - K952221- 30cc/40cc Sensation™ IAB; Model 930/940 IAB’s (Boston Scientific Corp.) Summ…
Datascope Corp.1979—
*K952221BSC/CA 30 & 40 Sensation, Models 930 & 940
Summary page 1
…marketed devices: - Datascope Percor STAT-DL®9.5Fr.&10.5Fr. Intra-Aortic Balloons, K940231 & K940178. - K905663 - Pediatric IAB - K790775 - Datascope Type “S” IAB - K952221- 30cc/40cc Sensation™ IAB; Model 930/940 IAB’s (Boston Scientific Corp.) Summary of Safety & Effectiveness/Datasc…
Boston Scientific Corp1995—
*K9439199.5 FR Sensation DL Intra-Aortic Ballon Catheter
Summary page 2
…ensation™ IAB; Model 930/940 IAB’s (Boston Scientific Corp.) Summary of Safety & Effectiveness/Datascope Percor STAT-DL ®9.5 & 10.5Fr. IAB Page 2 D. - K943919 - 9.5 Fr. Sensation™IAB (Boston Scientific Corp.) - K961358 - 8.0 Fr. 30/40cc, 10.0 Fr. 50cc Sheathless IAB (Arrow International…
Boston Scientific Corp1995—
*K961358Arrow Sheathless Intra-Aortic Balloon Catheter
Summary page 2
…Summary of Safety & Effectiveness/Datascope Percor STAT-DL ®9.5 & 10.5Fr. IAB Page 2 D. - K943919 - 9.5 Fr. Sensation™IAB (Boston Scientific Corp.) - K961358 - 8.0 Fr. 30/40cc, 10.0 Fr. 50cc Sheathless IAB (Arrow International) VICE PT N The intra-aortic balloon is placed in the desce…
Arrow Intl., Inc.1996—

Also cleared against K940231: 3 other devices →

What descends from it? (20)

See all 20

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

NumberDeviceApplicantDecidedDescendants
K980385Datascope 8FR. CO-Lumen 34 and 40CC Intra-Aortic Balloon Catheters for Optional…Datascope Corp.199817
K980780Datascope Percor Stat-DL 9.5 FR. 25, 34 and 40CC Intra-Aoric Balloons with Alternate B…Datascope Corp.199816
K020257Datascope's 8FR. Alt B Iab; Datascope's Profile 8FR. Alt B Iab; Datascope's True…Datascope Corp.20020
K973007Datascope's 10 FR. Flexisheath Percutaneous IntroducerDatascope Corp.19970

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

Recalls of this device

DateClassRecallRoot causeReason
Mar 21, 2003Not classifiedZ-0916-03Other10.5 Fr. Percor STAT-DL Intra-Aortic Balloon Insertion Kit, Introducer Sheath failed water leak test during final inspection.

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 · 4 generations on · ◆ in the 2007 descendants bar of FIG. 11 Class I recall
  • K112372Cardiosave Hybrid Intra-Aortic Balloon PumpCardiac Assist, Maquet Cardiovascular, LLC · 2011 · 5 generations on · ◆ in the 2011 descendants bar of FIG. 110 Class I recalls
  • K181122CARDIOSAVE Intra-Aortic Balloon PumpDatascope Corp. · 2018 · 6 generations on · ◆ in the 2018 descendants bar of FIG. 127 Class I recalls
  • K151254CARDIOSAVE Hybrid Intra-Aortic Balloon PumpDatascope Corp. · 2015 · 6 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 · 7 generations on · ◆ in the 2017 descendants bar of FIG. 17 Class I recalls

What does this lineage say?

  • None of the 7 ancestors has a recall.
  • Of its descendants, K980385 (Datascope Corp., 1998) has gone furthest, with 17 descendants of its own.
  • 3 other devices also cite its predicate K940231.

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?

The intra-aortic balloon is placed in the descending aorta just below the subclavian artery and is intended to improve cardiovascular functioning during the following situations:

Refractory ventricular failure

Cardiogenic shock

Unstable refractory angina

Impending infarction

Mechanical complications due to acute myocardial infarction

Ischemic related intractable ventricular arrhythmias

Cardiac support for high risk surgical patients and coronary angiography or angioplasty patients

Septic shock .

Weaning from cardiopulmonary bypass

Interoperative 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 K940231

3 other devices cite the same predicate.

  • K980780Datascope Percor Stat-DL 9.5 FR. 25, 34 and 40CC Intra-Aoric Balloons with Alternate B Membrane for Optional…Datascope Corp. · 1998
  • K980385Datascope 8FR. CO-Lumen 34 and 40CC Intra-Aortic Balloon Catheters for Optional Sheathless Insertion with…Datascope Corp. · 1998
  • K973007Datascope's 10 FR. Flexisheath Percutaneous IntroducerDatascope Corp. · 1997

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/K964987 · printed Nov 4, 2026

Cite this page

510(k) Report. “K964987: Datascope Percor Stat - DL 9.5 FR. 25 and 40CC Intra-Aortic Balloon for Optional Sheathless Insertion and Percor Stat -0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K964987

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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