510(k) Report

FDA applicant

Datascope Corp., Cardiac Assist Division

Fairfield, NJ4 decisions2009–201210 recalls

FDA records 4 decisions for Datascope Corp., Cardiac Assist Division (Fairfield, NJ) from 2009 to 2012: 4 510(k) clearances. Most are in product codes DSP (System, Balloon, Intra-Aortic And Control) and DXC (Clamp, Vascular). Its devices cite 8 predicates, 1 of them its own earlier devices. 10 recalls are linked to its devices.

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 Datascope Corp., Cardiac Assist Division’s devices, and how often a recall has named them.

FDA decisions per year

3in 2012

2009: 12012: 3
2009high 3 (2012) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

2in 2023

2016: 12018: 22019: 12020: 42023: 2
2009high 4 (2020) · low 0 (2009)2026

Class I Class II/III not classified

FIG. 1 — Datascope Corp., Cardiac Assist Division by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Datascope Corp., Cardiac Assist Division’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • DSPSystem, Balloon, Intra-Aortic And Control3decisions
  • DXCClamp, Vascular1decision

Whose devices does it build on?

Its devices cite 8 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 1 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.

  • K091449Datascope's 8FR. 50CC Intra-Aortic Balloon Catheter and Accessories, Models 0684,00-0498-01, 02Datascope Corp., Cardiac Assist Division · 20092cite it
  • K122405Air-Band Radial Compression DeviceDatascope Corp., Cardiac Assist Division · 20122cite it
  • K120868Mega (TM) 7.5FR. 30CC Intra-Aortic Balloon Catheter and Accessories, Mega (TM) 7.5FR. 40CC Intra-Aortic…Datascope Corp., Cardiac Assist Division · 20121cites it

What has FDA decided for it lately?

  • K122405Air-Band Radial Compression DeviceDatascope Corp., Cardiac Assist Division · 2012
  • K122628Sensation Plus 7.5FR. 40CC Intra-Aortic Balloon (Iab) Catheter and AccessoriesDatascope Corp., Cardiac Assist Division · 20123 recalls
  • K120868Mega (TM) 7.5FR. 30CC Intra-Aortic Balloon Catheter and Accessories, Mega (TM) 7.5FR. 40CC Intra-Aortic…Datascope Corp., Cardiac Assist Division · 20127 recalls
  • K091449Datascope's 8FR. 50CC Intra-Aortic Balloon Catheter and Accessories, Models 0684,00-0498-01, 02Datascope Corp., Cardiac Assist Division · 2009

All 4 as Datascope Corp., Cardiac Assist Division →

What has been recalled?

10 recalls linked to its devices; the latest:

  • K122628SENSATION PLUS 7.5Fr IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide…Jun 23, 2023Class II
  • K120868MEGA 7.5Fr.IAB , Intra-Aortic Balloon Catheter and Accessories, used to provide counter…Jun 23, 2023Class II
  • K122628Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation Plus 7.5 Fr 40cc IAB Kit P/N…Jul 27, 2020Class II
  • K120868Datascope Intra-Aortic Balloon Catheters (IABs)-MEGA 7.5Fr 40cc IAB Kit P/N…Jul 27, 2020Class II
  • K120868Datascope Intra-Aortic Ballon Catheters (IABs)-MEGA 7.5Fr 30cc IAB, P/N…Jul 27, 2020Class II
  • K120868Datascope Intra-Aortic Ballon Catheters (IABs)-MEGA 8Fr 50cc IAB Kit P/N…Jul 27, 2020Class II

Other applicant names beginning “Datascope”

FDA records each applicant name separately; these may or may not be the same firm.

Datascope Corp. 137Datascope Corp., Patient Monitoring Division 4