VAS-CATH URETERAL STENTS CATHETER, MODIFICATION— 510(k) K905505

Name: FDA 510(k) clearance K905505
Creator: U.S. Food and Drug Administration
Published: 1991-04-09

Substantially Equivalent

Vas-Cath, Inc.

FDA 510(k) clearance K905505 for VAS-CATH URETERAL STENTS CATHETER, MODIFICATION, Substantially Equivalent on 1991-04-09. Applicant: Vas-Cath, Inc.. Device class: 2.

Clearance details

Applicant: Vas-Cath, Inc.
Product code: Code FAD
Device class: Class 2
Regulation: 21 CFR 876.4620
Advisory panel: Gastroenterology, Urology
Date received: 1990-11-23
Decision date: 1991-04-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mississauga, Ontario, CA

Download summary PDF View on FDA.gov ↗

Recent devices under product code FAD

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K251890 — Disposable Ureteral Stents2026-02-20
K251469 — Endura Ureteral Stent and Stent Set2025-12-19
K243039 — Ureteral Stents (AF-D series)2025-06-18
K243830 — Disposable ureteral stent2025-05-14
K250824 — Percuflex Ureteral Stent +11 more2025-04-15

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 FAD

product code FAD

Death: 2
Injury: 858
Malfunction: 2,651
Other: 1
Total: 3,512

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.