SCIMED 6 FRENCH MICRO-MAX GUIDE CATHETER— 510(k) K953909

Name: FDA 510(k) clearance K953909
Creator: U.S. Food and Drug Administration
Published: 1995-11-13

Substantially Equivalent

Scimed

FDA 510(k) clearance K953909 for SCIMED 6 FRENCH MICRO-MAX GUIDE CATHETER, Substantially Equivalent on 1995-11-13. Applicant: Scimed. Device class: 2.

Clearance details

Applicant: Scimed
Product code: Code DQY
Device class: Class 2
Regulation: 21 CFR 870.1250
Advisory panel: Cardiovascular
Date received: 1995-08-21
Decision date: 1995-11-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Maple Grove, MN, US

Download summary PDF View on FDA.gov ↗

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K260559 — NHanceIT2026-08-14
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K262240 — SSPC NXT Delivery Catheter2026-07-29
K261825 — Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP Catheter2026-07-02

More clearances from Scimed

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K992142 — SCIMED ANGIOGRAPHIC CATHETERS1999-07-21
K931584 — SCIMED TRANSPORT STEERABLE GUIDE WIRE AND ACCESS.1993-07-01
K922706 — SCIMED SIDELINER1992-12-10
K915347 — SCIMED VIPER CATHETER1992-08-17
K910987 — 7FR. AND 8FR. TRIGUIDE GUIDING CATHETER ADD. CURVE1991-05-29

Adverse events under product code DQY

product code DQY

Death: 464
Injury: 4,489
Malfunction: 13,721
Other: 2
Total: 18,676

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.