ACI SILICATH THORACIC CATHETER— 510(k) K942335

Name: FDA 510(k) clearance K942335
Creator: U.S. Food and Drug Administration
Published: 1994-08-09

Substantially Equivalent

American Catheter

FDA 510(k) clearance K942335 for ACI SILICATH THORACIC CATHETER, Substantially Equivalent on 1994-08-09. Applicant: American Catheter. Device class: 1.

Clearance details

Applicant: American Catheter
Product code: Code GBX
Device class: Class 1
Regulation: 21 CFR 878.4200
Advisory panel: General, Plastic Surgery
Date received: 1994-05-16
Decision date: 1994-08-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Branford, CT, US

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Adverse events under product code GBX

product code GBX

Death: 16
Injury: 583
Malfunction: 3,578
Other: 1
Total: 4,178

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.