OPTI-PLAST 5F PTA CATHETERS OVEN CURING PROCEDURE— 510(k) K911639

Substantially Equivalent

Vas-Cath, Inc.

FDA 510(k) clearance K911639 for OPTI-PLAST 5F PTA CATHETERS OVEN CURING PROCEDURE, Substantially Equivalent on 1991-06-11. Applicant: Vas-Cath, Inc..

Clearance details

Applicant: Vas-Cath, Inc.
Product code: Code LIT
Advisory panel: Cardiovascular
Date received: 1991-02-20
Decision date: 1991-06-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mississauga,Ontario, CA

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Adverse events under product code LIT

product code LIT

Death: 27
Injury: 1,256
Malfunction: 12,127
Total: 13,410

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.