510(k) Report

510(k) · Cleared

Cleared

40 CC Grande

K974247510(k) TraditionalCleared Feb 10, 199890-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

Boston Scientific Corp · DSP System, Balloon, Intra-Aortic And Control

Cleared on Feb 10, 1998 as substantially equivalent to K971673 (Boston Scientific Corp, 1997) and 4 other predicates after a 90-day review. Its family tree reaches back 3 generations to 1990.

Decided
Feb 10, 1998
Review
90 days
Class
Class II
Product code
DSP
Recalls
None
Predicates
5

Its longest line of descent runs back 3 generations to K892222 (1990). 8 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1996: 1 other ancestor1995: 3 other ancestors1991: 1 other ancestorK892222 · 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 · 1996K971673 · 40 CC Sumo · Boston Scientific Corp · 1997199019921994199619982000
Other ancestors, by generation 1 generation back: 3 other ancestors2 generations back: 2 other ancestors K971673 · 40 CC Sumo · 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. · 19900
  1. Root · 3 generations backK892222 9.5F Percu Double Lumen Intra-Aortic BalloonKontron Instruments, Inc. · 1990
  2. 2 generations backK963187 Modified Labeling of Cardiac Assist Intra-Aortic Balloon Catheters…Boston Scientific Corp · 1996
  3. 1 generation backK971673 40 CC SumoBoston Scientific Corp · 1997
  4. This deviceK974247 40 CC GrandeBoston Scientific Corp · 1998
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K8922229.5F Percu Double Lumen Intra-Aortic BalloonKontron Instruments, Inc.1990—
−2K963187Modified Labeling of Cardiac Assist Intra-Aortic Balloon Catheters: Model 930…Boston Scientific Corp1996—
−1K97167340 CC SumoBoston Scientific Corp1997—
0 (this device)K97424740 CC GrandeBoston Scientific Corp1998—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199110
199530
199610
FIG. 1 — Lineage of K974247, 1990–1998Source: 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.

Planning a device in DSP? 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
*K97167340 CC Sumo
Summary page 1
…REDICATE DEVICE INFORMATION The following devices are referenced in this premarket notification as predicate devices for the 40 cc Grande™, subject of this submission: K971673: 40 cc SUMO for use on BSC/CA 3001, Datascope Systems 90 and 97, Kontron KAAT, St. Jude/Aries 700 and Bard H-8000. K963187: Modi…
Boston Scientific Corp1997—
*K963187Modified Labeling of Cardiac Assist Intra-Aortic Balloon Catheters: Model 930 - 940, 30…
Summary page 1
…e 40 cc Grande™, subject of this submission: K971673: 40 cc SUMO for use on BSC/CA 3001, Datascope Systems 90 and 97, Kontron KAAT, St. Jude/Aries 700 and Bard H-8000. K963187: Modified labeling of BSC/CA IAB’s. K954431: Modified Model 940 and Model 930 for use on BSC/CA 3001, [B):tgsfiope Systems 90 an…
Boston Scientific Corp1996—
*K954431Percutaneous Intra-Aortic Balloon Catheters
Summary page 1
…K971673: 40 cc SUMO for use on BSC/CA 3001, Datascope Systems 90 and 97, Kontron KAAT, St. Jude/Aries 700 and Bard H-8000. K963187: Modified labeling of BSC/CA IAB’s. K954431: Modified Model 940 and Model 930 for use on BSC/CA 3001, [B):tgsfiope Systems 90 and 97, Kontron KAAT, St. Jude/Aries 700 and rd…
Boston Scientific Corp1996—
*K952221BSC/CA 30 & 40 Sensation, Models 930 & 940
Summary page 1
…ling of BSC/CA IAB’s. K954431: Modified Model 940 and Model 930 for use on BSC/CA 3001, [B):tgsfiope Systems 90 and 97, Kontron KAAT, St. Jude/Aries 700 and rd H-8000. K952221: 30 cc and 40 cc Sensation™, Model 940 and Model 930 for use on Bard H-8000. K940298: Model 940 for use on BSC/CA 3001, Datascop…
Boston Scientific Corp1995—
*K940298BSC/CA Model 940 Iab
Summary page 1
…1, [B):tgsfiope Systems 90 and 97, Kontron KAAT, St. Jude/Aries 700 and rd H-8000. K952221: 30 cc and 40 cc Sensation™, Model 940 and Model 930 for use on Bard H-8000. K940298: Model 940 for use on BSC/CA 3001, Datascope Systems 90 and 97, Kontron KAAT and St. Jude/Aries 700. 000014 FDA…
Boston Scientific Corp1995—
*—40 cc Grande NT™
Named without a submission number
—
*—Model 940
Named without a submission number
—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 8 years and passes through 2 companies; a new generation was cleared every 9 months on median.
  • None of the 8 ancestors has a recall.

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 BSC/CA IABC'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 40 cc…

Read the full statement (213 words)

The BSC/CA IABC'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 40 cc Grande'' remains identicalto 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 (MVOZ).

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 and intra-aortic balloon catheter into the descending thoracic aorta via the cammon fémoral 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.

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https://510kreport.com/device/K974247 · printed Nov 5, 2026

Cite this page

510(k) Report. “K974247: 40 CC Grande.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K974247

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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