9.5 FR SENSATION DL INTRA-AORTIC BALLON CATHETER— 510(k) K943919

Name: FDA 510(k) clearance K943919
Creator: U.S. Food and Drug Administration
Published: 1995-03-23

Substantially Equivalent

Boston Scientific Corp

FDA 510(k) clearance K943919 for 9.5 FR SENSATION DL INTRA-AORTIC BALLON CATHETER, Substantially Equivalent on 1995-03-23. Applicant: Boston Scientific Corp. Device class: 2.

Clearance details

Applicant: Boston Scientific Corp
Product code: Code DSP
Device class: Class 2
Regulation: 21 CFR 870.3535
Advisory panel: Cardiovascular
Date received: 1994-08-12
Decision date: 1995-03-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Watertown, MA, US

Download summary PDF View on FDA.gov ↗

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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.