OPTI-PLAST 5F PTA CATHETERS, MODIFICATION— 510(k) K912984

Name: FDA 510(k) clearance K912984
Creator: U.S. Food and Drug Administration
Published: 1991-08-13

Substantially Equivalent

Vas-Cath, Inc.

FDA 510(k) clearance K912984 for OPTI-PLAST 5F PTA CATHETERS, MODIFICATION, Substantially Equivalent on 1991-08-13. Applicant: Vas-Cath, Inc.. Device class: 2.

Clearance details

Applicant: Vas-Cath, Inc.
Product code: Code LIT
Device class: Class 2
Regulation: 21 CFR 870.1250
Advisory panel: Cardiovascular
Date received: 1991-06-28
Decision date: 1991-08-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mississauga, Ontario, CA

Download summary PDF View on FDA.gov ↗

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More clearances from Vas-Cath, Inc.

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K973013 — OPTI-PLAST (CENTURION) 5.5F ANGIOPLASTY CATHETER1998-06-19
K965178 — NIAGARA DUAL LUMEN CATHETER1997-08-19
K964881 — ULTRAVERSE PTA CATHETER1997-05-28
K970725 — OPTI-PLAST XL 5.5 F PTA CATHETER1997-05-09
K941706 — OPTI-PLAST ANGIOPLASTY CATHETER1994-10-18

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.