PATCH,PLEDGET AND INTRACARDIAC,PETP,PTFE,POLYPROPYLENE— 510(k) K972201

Substantially Equivalent

Sulzer Carbomedics, Inc.

FDA 510(k) clearance K972201 for PATCH,PLEDGET AND INTRACARDIAC,PETP,PTFE,POLYPROPYLENE, Substantially Equivalent on 1998-04-14. Applicant: Sulzer Carbomedics, Inc..

Clearance details

Applicant: Sulzer Carbomedics, Inc.
Product code: Code DXZ
Advisory panel: Cardiovascular
Date received: 1997-06-11
Decision date: 1998-04-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

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Adverse events under product code DXZ

product code DXZ

Death: 19
Injury: 265
Total: 284

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.