510(k) · Cleared
Cleared8 FR.-30CC Narrowflex Intra-Aortic Balloon Catheter,
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arrow Intl., Inc. · DSP System, Balloon, Intra-Aortic And Control
Cleared on Jun 17, 1997 as substantially equivalent to K960713 (Arrow Intl., Inc., 1996) and 1 other predicate after a 260-day review. Its family tree reaches back 1 generation to 1989. 10 of the 22 devices in its family, counting itself, have a Class I recall. 19 later devices descend from it.
- Decided
- Jun 17, 1997
- Review
- 260 days
- Class
- Class II
- Product code
- DSP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K892799 (1989). 2 ancestors in all. 19 later devices descend from it, 2 citing it directly. 10 of the 22 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK892799 8 FR Percutan Double Lumen Intra-Aortic BalloonKontron Instruments, Inc. · 1989
- This deviceK963920 8 FR.-30CC Narrowflex Intra-Aortic Balloon Catheter,Arrow Intl., Inc. · 1997
- Descendant · cites it directly · 18 of its ownK021462 Arrow Intra-Aortic Balloon (Iab) Catheter with a Fiber Optic Sensor…Arrow Intl., Inc. · 2002 · Recalled (Class I)
- Descendant · 2 generations on · 14 of its ownK060309 Autocat Intra-Aortic Balloon Pump SeriesArrow Intl., Inc. · 2006 · Recalled (Class I)
- Descendant · cites it directly · 9 of its ownK040801 Intra-Aortic Balloon (Iab)Arrow Intl., Inc. · 2004 · Recalled
- Descendant · 2 generations on · 8 of its ownK063525 Datascope Fiber Optic Pressure Sensor Intra-Aortic Balloon Catheter…Datascope Corp. · 2007 · Recalled (Class I)
- Descendant · 3 generations on · 4 of its ownK162820 AC3 Series IABP SystemArrow International, Inc. · 2017 · Recalled (Class I)
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K021462 Arrow Intra-Aortic Balloon (Iab) Catheter with a…cites it directly · 2002
- K200634 Arrow FiberOptix Intra-Aortic Balloon Catheter Kit2 generations on · 2020
- K063525 Datascope Fiber Optic Pressure Sensor…2 generations on · 2007
- K060309 Autocat Intra-Aortic Balloon Pump Series2 generations on · 2006
Most influential descendants
Showing 5 of 19 · See all- K021462Arrow Intra-Aortic Balloon (Iab) Catheter with a Fiber Optic Sensor and a Measurement…Arrow Intl., Inc. · 2002 · cites it directly18descendants
- K060309Autocat Intra-Aortic Balloon Pump SeriesArrow Intl., Inc. · 2006 · 2 generations on14descendants
- K040801Intra-Aortic Balloon (Iab)Arrow Intl., Inc. · 2004 · cites it directly9descendants
- K063525Datascope Fiber Optic Pressure Sensor Intra-Aortic Balloon Catheter and CS300…Datascope Corp. · 2007 · 2 generations on8descendants
- K162820AC3 Series IABP SystemArrow International, Inc. · 2017 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K892799 | 8 FR Percutan Double Lumen Intra-Aortic Balloon | Kontron Instruments, Inc. | 1989 | — |
| 0 (this device) | K963920 | 8 FR.-30CC Narrowflex Intra-Aortic Balloon Catheter, | Arrow Intl., Inc. | 1997 | — |
| +1 | K021462 | Arrow Intra-Aortic Balloon (Iab) Catheter with a Fiber Optic Sensor and a… | Arrow Intl., Inc. | 2002 | Class I |
| +2 | K060309 | Autocat Intra-Aortic Balloon Pump Series | Arrow Intl., Inc. | 2006 | Class I |
| +1 | K040801 | Intra-Aortic Balloon (Iab) | Arrow Intl., Inc. | 2004 | 13 |
| +2 | K063525 | Datascope Fiber Optic Pressure Sensor Intra-Aortic Balloon Catheter and CS300… | Datascope Corp. | 2007 | Class I |
| +3 | K162820 | AC3 Series IABP System | Arrow International, Inc. | 2017 | Class I |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 1 |
| 2004 | 1 | 0 |
| 2006 | 1 | 1 |
| 2007 | 1 | 1 |
| 2011 | 2 | 1 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 1 |
| 2017 | 3 | 2 |
| 2018 | 1 | 1 |
| 2019 | 2 | 0 |
| 2020 | 2 | 2 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
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.
10 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
What was it cleared against? (2)
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 | Decided |
|---|---|---|---|
| * | K960713 | 8 FR.-40CC Arrow Flex Intra-Aortic Balloon Catheter with Blue Flex Tip, Product Number…Summary page 1…ted Arrow intra-aortic balloon devices: 1. 8 Fr-40cc NarrowFlex™, with Nitinol inner lumen and kink resistant outer lumen, product no. 1AB-04840, premarket notification K960713. 2. 8 Fr-30cc, with stainless steel inner lumen and plastic outer lumen, product no. IAB-04230, premarket notification K892799.… | 1996 |
| * | K892799 | 8 FR Percutan Double Lumen Intra-Aortic BalloonSummary page 1…uct no. 1AB-04840, premarket notification K960713. 2. 8 Fr-30cc, with stainless steel inner lumen and plastic outer lumen, product no. IAB-04230, premarket notification K892799. This device is identical in construction to the predicate 8 Fr-40cc NarrowFlex™ device |IAB- 04840 with the exception of the 30… | 1989 |
What descends from it? (19)
See all 192 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (10 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.
- K021462Arrow Intra-Aortic Balloon (Iab) Catheter with a Fiber Optic Sensor and a Measurement System, Models…Arrow Intl., Inc. · 2002 · Cites it directly · ◆ in the 2002 descendants bar of FIG. 12 Class I recalls
- K200634Arrow FiberOptix Intra-Aortic Balloon Catheter KitArrow International, Inc. · 2020 · 2 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
- K063525Datascope Fiber Optic Pressure Sensor Intra-Aortic Balloon Catheter and CS300 Intra-Aortic Balloon Pump…Datascope Corp. · 2007 · 2 generations on · ◆ in the 2007 descendants bar of FIG. 11 Class I recall
- K060309Autocat Intra-Aortic Balloon Pump SeriesArrow Intl., Inc. · 2006 · 2 generations on · ◆ in the 2006 descendants bar of FIG. 128 Class I recalls
- K201112AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABPArrow International, Inc. · 2020 · 3 generations on · ◆ in the 2020 descendants bar of FIG. 111 Class I recalls
- K162820AC3 Series IABP SystemArrow International, Inc. · 2017 · 3 generations on · ◆ in the 2017 descendants bar of FIG. 12 Class I recalls
- K112372Cardiosave Hybrid Intra-Aortic Balloon PumpCardiac Assist, Maquet Cardiovascular, LLC · 2011 · 3 generations on · ◆ in the 2011 descendants bar of FIG. 110 Class I recalls
- K181122CARDIOSAVE Intra-Aortic Balloon PumpDatascope Corp. · 2018 · 4 generations on · ◆ in the 2018 descendants bar of FIG. 127 Class I recalls
- K151254CARDIOSAVE Hybrid Intra-Aortic Balloon PumpDatascope Corp. · 2015 · 4 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 · 5 generations on · ◆ in the 2017 descendants bar of FIG. 17 Class I recalls
Nearest 5 of 10; all are on the web page.
What does this lineage say?
How does its category compare?
All DSP devicesDSP 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
2026 to Oct 25, outlined.
Median 510(k) review, days · DSP
140in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DSP
4in 2025
Class I (47 since 2007) Class II/III not classified
Adverse event reports per year · DSP
7,422in 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 left ventricular power failure. Cardiogenic shock unstable refractory angina. Mechanical complication due to acute myocardial infraction; i.e., ventricular sepial defect mitral regurgitation or papillary muscle rupture. Impending infraction, ischemia related intractable ventricular arrhythmias. Septic shock. Support for failed angioplasty and valvuloplasty. Cardiac support for high risk general surgical patients.
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/K963920 · printed Nov 4, 2026
Cite this page
510(k) Report. “K963920: 8 FR.-30CC Narrowflex Intra-Aortic Balloon Catheter,.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K963920
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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