SCIMED VIPER CATHETER— 510(k) K915347

Name: FDA 510(k) clearance K915347
Creator: U.S. Food and Drug Administration
Published: 1992-08-17

Substantially Equivalent

Scimed

FDA 510(k) clearance K915347 for SCIMED VIPER CATHETER, Substantially Equivalent on 1992-08-17. Applicant: Scimed. Device class: 2.

Clearance details

Applicant: Scimed
Product code: Code LIT
Device class: Class 2
Regulation: 21 CFR 870.1250
Advisory panel: Cardiovascular
Date received: 1991-11-26
Decision date: 1992-08-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Maple Grove, MN, US

Download summary PDF View on FDA.gov ↗

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K931584 — SCIMED TRANSPORT STEERABLE GUIDE WIRE AND ACCESS.1993-07-01
K922706 — SCIMED SIDELINER1992-12-10
K910987 — 7FR. AND 8FR. TRIGUIDE GUIDING CATHETER ADD. CURVE1991-05-29

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.