DATASCOPE'S 8FR. 50CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES, MODELS 0684,00-0498-01, 02— 510(k) K091449

Name: FDA 510(k) clearance K091449
Creator: U.S. Food and Drug Administration
Published: 2009-06-18

Substantially Equivalent

Datascope Corp., Cardiac Assist Division

FDA 510(k) clearance K091449 for DATASCOPE'S 8FR. 50CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES, MODELS 0684,00-0498-01, 02, Substantially Equivalent on 2009-06-18. Applicant: Datascope Corp., Cardiac Assist Division. Device class: 2.

Clearance details

Applicant: Datascope Corp., Cardiac Assist Division
Product code: Code DSP
Device class: Class 2
Regulation: 21 CFR 870.3535
Advisory panel: Cardiovascular
Date received: 2009-05-18
Decision date: 2009-06-18
Decision: Substantially Equivalent
Clearance type: Special
Location: Fairfield, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DSP

view all

K250542 — AC3 Range Intra-Aortic Balloon Pump2025-03-26
K232343 — AC3 Series IABP2023-08-30
K201112 — AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABP2020-05-27
K200634 — Arrow FiberOptix Intra-Aortic Balloon Catheter Kit2020-04-09
K192238 — AC3 Series Intra-Aortic Balloon Pump (IABP)2019-11-12

More clearances from Datascope Corp., Cardiac Assist Division

view all

Adverse events under product code DSP

product code DSP

Death: 317
Injury: 566
Malfunction: 36,831
Other: 4
Total: 37,718

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.