510(k) Report

FDA applicant

Cardiac Assist, Maquet Cardiovascular, LLC

Manwah, NJ2 decisions2011–201132 recalls

FDA records 2 decisions for Cardiac Assist, Maquet Cardiovascular, LLC (Manwah, NJ) in 2011: 2 510(k) clearances. All are in product code DSP (System, Balloon, Intra-Aortic And Control). Its devices cite 3 predicates, 0 of them its own earlier devices. 32 recalls are linked to its devices, 10 Class I.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Cardiac Assist, Maquet Cardiovascular, LLC’s devices, and how often a recall has named them.

FDA decisions per year

2in 2011

2011: 2
2011high 2 (2011) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

1in 2026

2012: 12014: 12015: 22016: 12018: 1, 1 Class I2019: 4, 4 Class I2021: 7, 3 Class I2023: 10, 2 Class I2024: 12025: 32026 (partial year): 1
2011high 10 (2023) · low 0 (2011)2026

Class I Class II/III not classified

FIG. 1 — Cardiac Assist, Maquet Cardiovascular, LLC by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • DSPSystem, Balloon, Intra-Aortic And Control2decisions

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K112327Sensation (TM) Plus 8FR. 50CC Intra-Aortic Balloon Catheter and AccessoriesCardiac Assist, Maquet Cardiovascular, LLC · 20112cite it
  • K112372Cardiosave Hybrid Intra-Aortic Balloon PumpCardiac Assist, Maquet Cardiovascular, LLC · 20112cite it

What has FDA decided for it lately?

  • K112372Cardiosave Hybrid Intra-Aortic Balloon PumpCardiac Assist, Maquet Cardiovascular, LLC · 201110 Class I recalls
  • K112327Sensation (TM) Plus 8FR. 50CC Intra-Aortic Balloon Catheter and AccessoriesCardiac Assist, Maquet Cardiovascular, LLC · 20111 recall

All 2 as Cardiac Assist, Maquet Cardiovascular, LLC →

What has been recalled?

32 recalls linked to its devices; the latest:

  • K112372Battery Charging Station; Model: 0998-00-0802;Feb 6, 2026Class III
  • K112372Cardiosave Hybrid. Intra-Aortic Balloon Pump system.Nov 4, 2025Class II
  • K112372Cardiosave RescueOct 23, 2025Class III
  • K112372Cardiosave HybridOct 23, 2025Class III
  • K133074MEGA 7.5Fr. 40cc Intra-Aortic Balloon with Accessories, Model Number 0684-00- 0295-01Sep 17, 2024Class II
  • K112372Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Model Number 0998-00-0800-55, Part…May 4, 2023Class III