510(k) · Cleared
Cleared30 CC and 40 CC Sub-9 Nitinol and 30 and 40 CC Sub-9 Stainless Steel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corp · DSP System, Balloon, Intra-Aortic And Control
Cleared on Sep 2, 1997 as substantially equivalent to K963187 (Boston Scientific Corp, 1996) and 5 other predicates after an 89-day review. Its family tree reaches back 2 generations to 1990. 5 of the 27 devices in its family, counting itself, have a Class I recall. 18 later devices descend from it.
- Decided
- Sep 2, 1997
- Review
- 89 days
- Class
- Class II
- Product code
- DSP
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 2 generations to K892222 (1990). 8 ancestors in all. 18 later devices descend from it, 1 citing it directly. 5 of the 27 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK892222 9.5F Percu Double Lumen Intra-Aortic BalloonKontron Instruments, Inc. · 1990
- 1 generation backK963187 Modified Labeling of Cardiac Assist Intra-Aortic Balloon Catheters…Boston Scientific Corp · 1996
- This deviceK972113 30 CC and 40 CC Sub-9 Nitinol and 30 and 40 CC Sub-9 Stainless SteelBoston Scientific Corp · 1997
- Descendant · cites it directly · 17 of its ownK980385 Datascope 8FR. CO-Lumen 34 and 40CC Intra-Aortic Balloon Catheters…Datascope Corp. · 1998
- Descendant · 2 generations on · 15 of its ownK994157 Datascope's 8FR. Polymide 25CC,34CC and 40CC Iab and Accessories…Datascope Corp. · 2000
- Descendant · 3 generations on · 14 of its ownK013326 Modification to: Datascope 8FR. Polyimide Alt B Iab, 25CC, 34CC…Datascope Corp. · 2001
- Descendant · 4 generations on · 12 of its ownK031569 Datascope CA 40 8FR. Iabs, Model 0684-00-04XXDatascope Corp. · 2003
- Descendant · 4 generations on · 11 of its ownK041281 Datascope 7.5FR. Iab Catheter and AccessoriesDatascope Corp. · 2004 · Recalled
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 18 · See all- K980385Datascope 8FR. CO-Lumen 34 and 40CC Intra-Aortic Balloon Catheters for Optional…Datascope Corp. · 1998 · cites it directly17descendants
- 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
- K041281Datascope 7.5FR. Iab Catheter and AccessoriesDatascope Corp. · 2004 · 4 generations on11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K892222 | 9.5F Percu Double Lumen Intra-Aortic Balloon | Kontron Instruments, Inc. | 1990 | — |
| −1 | K963187 | Modified Labeling of Cardiac Assist Intra-Aortic Balloon Catheters: Model 930… | Boston Scientific Corp | 1996 | — |
| 0 (this device) | K972113 | 30 CC and 40 CC Sub-9 Nitinol and 30 and 40 CC Sub-9 Stainless Steel | Boston Scientific Corp | 1997 | — |
| +1 | K980385 | Datascope 8FR. CO-Lumen 34 and 40CC Intra-Aortic Balloon Catheters for… | Datascope Corp. | 1998 | — |
| +2 | K994157 | Datascope's 8FR. Polymide 25CC,34CC and 40CC Iab and Accessories, Models… | Datascope Corp. | 2000 | — |
| +3 | K013326 | Modification to: Datascope 8FR. Polyimide Alt B Iab, 25CC, 34CC, 40CC… | Datascope Corp. | 2001 | — |
| +4 | K031569 | Datascope CA 40 8FR. Iabs, Model 0684-00-04XX | Datascope Corp. | 2003 | — |
| +4 | K041281 | Datascope 7.5FR. Iab Catheter and Accessories | Datascope Corp. | 2004 | 7 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 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 |
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
What was it cleared against? (6)
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 |
|---|---|---|---|
| * | K963187 | Modified Labeling of Cardiac Assist Intra-Aortic Balloon Catheters: Model 930 - 940, 30…Summary page 1…lowing devices are referenced in this premarket notification as predicate devices for the 30 cc and 40 cc SUB-9 Nitinol and Stainless Steel, subject of this submission: K963187: Modified Labeling of BSC/CA IAB’s. K954431: Modified Model 940 and Model 930 for use on BSC/CA 3001, Datascope Systems 90 and 9… | 1996 |
| * | K954431 | Percutaneous Intra-Aortic Balloon CathetersSummary page 1…et notification as predicate devices for the 30 cc and 40 cc SUB-9 Nitinol and Stainless Steel, subject of this submission: K963187: Modified Labeling of BSC/CA IAB’s. K954431: Modified Model 940 and Model 930 for use on BSC/CA 3001, Datascope Systems 90 and 97, St. Jude/Aries 700, Kontron KAAT and Bard… | 1996 |
| * | K952221 | BSC/CA 30 & 40 Sensation, Models 930 & 940Summary page 1…ling of BSC/CA IAB’s. K954431: Modified Model 940 and Model 930 for use on BSC/CA 3001, Datascope Systems 90 and 97, St. Jude/Aries 700, Kontron KAAT and Bard H-8000. K952221: 30 and 40 cc Sensation™, Model 940 and Model 930 for use on Bard H-8000. K943919: 40 cc Sensation™ for use on Datascope System… | 1995 |
| * | K943919 | 9.5 FR Sensation DL Intra-Aortic Ballon CatheterSummary page 1…3001, Datascope Systems 90 and 97, St. Jude/Aries 700, Kontron KAAT and Bard H-8000. K952221: 30 and 40 cc Sensation™, Model 940 and Model 930 for use on Bard H-8000. K943919: 40 cc Sensation™ for use on Datascope System 97 and St. Jude/Aries 700. 000743 K940298: Model 940 for use on BS… | 1995 |
| * | K940298 | BSC/CA Model 940 IabSummary page 2…cc Sensation™, Model 940 and Model 930 for use on Bard H-8000. K943919: 40 cc Sensation™ for use on Datascope System 97 and St. Jude/Aries 700. 000743 K940298: Model 940 for use on BSC/CA 3001, Datascope Systems 90 and 97, Kontron KAAT and St. Jude/Aries 700. K936232: Model 930 and 30 c… | 1995 |
| * | K936232 | BSC/CA Model 930 Iab, BSC/CA 30 SidewinderSummary page 2…e System 97 and St. Jude/Aries 700. 000743 K940298: Model 940 for use on BSC/CA 3001, Datascope Systems 90 and 97, Kontron KAAT and St. Jude/Aries 700. K936232: Model 930 and 30 cc Sensation™ for use on BSC/CA 3001, Datascope Systems 90 and 97, Kontron KAAT and St. Jude/Aries 700. FDA ha… | 1994 |
What descends from it? (18)
See all 181 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K980385 | Datascope 8FR. CO-Lumen 34 and 40CC Intra-Aortic Balloon Catheters for Optional… | 1998 | 17 |
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 · 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?
- The line of descent spans 7 years and passes through 2 companies; a new generation was cleared every 6.1 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K980385 (Datascope Corp., 1998) has gone furthest, with 17 descendants of its own.
- 2 other devices also cite its predicate K963187.
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?
BSC/CA IAB's are indicated for use in patients with the following conditions: * Refractory power failure. * Cardiogenic shock. * Unstable refractory angina. * Hemodynamically significant mechanical complications secondary to acute MI: * Ventricular septal defect. * Mitral valve regurgitation. * Papillary muscle rupture. * Cardiac support for high risk general surgical and coronary angiography/angioplasty patients. * Septic shock. The intended use of the…
Read the full statement (225 words)
BSC/CA IAB's are indicated for use in patients with the following conditions:
* Refractory power failure.
* Cardiogenic shock.
* Unstable refractory angina.
* Hemodynamically significant mechanical complications secondary to acute MI:
* Ventricular septal defect.
* Mitral valve regurgitation.
* Papillary muscle rupture.
* Cardiac support for high risk general surgical and coronary angiography/angioplasty patients.
* Septic shock.
The intended use of the 30 cc and 40 cc SUB-9 remain identical to that of the currently marketed IABC's. All of the devices are intended to provide temporary circulatory support of the left ventricle through controlled mechanical displacement of a volume of blood in the aorta.
The mechanical action of the IAB catheter therapy lowers the cardiac workload by two means:
1. Systolic unloading, as noted by a reduction in the patient's systolic pressure, which provides reduced myocardial oxygen consumption (MVO2).
2. Diastolic augmentation which provides an increase in the mean aortic pressure and leads to an improvement in systemic and coronary arterial perfusion.
Balloon pump therapy is achieved by inserting an intra-aortic balloon catheter into the descending thoracic aorta via the common femoral artery. Balloon inflation is timed to occur during diastole, beginning with the aortic valve closure. The balloon remains inflated until the onset of left ventricular ejection or systole, then rapidly deflates, reducing the aortic pressure, which in turn reduces the afterload.
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/K972113 · printed Nov 6, 2026
Cite this page
510(k) Report. “K972113: 30 CC and 40 CC Sub-9 Nitinol and 30 and 40 CC Sub-9 Stainless Steel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K972113
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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