EXTENSION SET WITH CHECK VALVE— 510(k) K954983

Substantially Equivalent

Distronic Sterile Products, Inc.

FDA 510(k) clearance K954983 for EXTENSION SET WITH CHECK VALVE, Substantially Equivalent on 1996-01-23. Applicant: Distronic Sterile Products, Inc..

Clearance details

Applicant: Distronic Sterile Products, Inc.
Product code: Code FPA
Advisory panel: General Hospital
Date received: 1995-10-31
Decision date: 1996-01-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Portsmouth, NH, US

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Adverse events under product code FPA

product code FPA

Death: 95
Injury: 14,421
Malfunction: 125,815
Other: 30
Total: 140,361

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.