SCIMED 0.014 PTCA GUIDE WIRE WITH ICE HYDROPHILIC COATING— 510(k) K941895

Name: FDA 510(k) clearance K941895
Creator: U.S. Food and Drug Administration
Published: 1994-05-24

Substantially Equivalent

Scimed Life Systems, Inc.

FDA 510(k) clearance K941895 for SCIMED 0.014 PTCA GUIDE WIRE WITH ICE HYDROPHILIC COATING, Substantially Equivalent on 1994-05-24. Applicant: Scimed Life Systems, Inc.. Device class: 2.

Clearance details

Applicant: Scimed Life Systems, Inc.
Product code: Code DQX
Device class: Class 2
Regulation: 21 CFR 870.1330
Advisory panel: Cardiovascular
Date received: 1994-04-18
Decision date: 1994-05-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plymouth, MN, US

Download summary PDF View on FDA.gov ↗

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K974241 — SCIMED INFORMER PRESSURE WIRE SYSTEM1998-11-12
K981788 — SCIMED 6 FRENCH WISEGUIDE GUIDE CATHETER1998-08-18
K980360 — SCIMED QUEST FLOPPY AND MODERATE SUPPORT GUIDE WIRES1998-04-29
K974559 — SCIMED 6 FRENCH IMPULSE ANGIOGRAPHIC CATHETERS1998-02-23
K974684 — SCIMED 7 FRENCH WISEGUIDE GUIDE CATHETER1998-02-19

Adverse events under product code DQX

product code DQX

Death: 298
Injury: 4,385
Malfunction: 7,203
Other: 5
Total: 11,891

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.