IMPACT BALLOON DILATION CATHETER— 510(k) K983373

Substantially Equivalent

B. Braun/Mcgaw

FDA 510(k) clearance K983373 for IMPACT BALLOON DILATION CATHETER, Substantially Equivalent on 1999-06-22. Applicant: B. Braun/Mcgaw.

Clearance details

Applicant: B. Braun/Mcgaw
Product code: Code KNQ
Advisory panel: Gastroenterology, Urology
Date received: 1998-09-24
Decision date: 1999-06-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bethlehem, PA, US

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Adverse events under product code KNQ

product code KNQ

Malfunction: 1,844
Total: 1,844

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.