ADI CATHETER WITH VALVE— 510(k) K952924

Substantially Equivalent

Asia Dynamics, Inc.

FDA 510(k) clearance K952924 for ADI CATHETER WITH VALVE, Substantially Equivalent on 1995-08-18. Applicant: Asia Dynamics, Inc..

Clearance details

Applicant: Asia Dynamics, Inc.
Product code: Code GBM
Advisory panel: Gastroenterology, Urology
Date received: 1995-06-26
Decision date: 1995-08-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Niles, IL, US

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Adverse events under product code GBM

product code GBM

Injury: 397
Malfunction: 1,404
Total: 1,801

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.