SCIMED CHOICE(TM) PTCA GUIDE WIRE— 510(k) K943192

Substantially Equivalent

Scimed Life Systems, Inc.

FDA 510(k) clearance K943192 for SCIMED CHOICE(TM) PTCA GUIDE WIRE, Substantially Equivalent on 1994-11-22. Applicant: Scimed Life Systems, Inc..

Clearance details

Applicant: Scimed Life Systems, Inc.
Product code: Code DQO
Advisory panel: Cardiovascular
Date received: 1994-07-05
Decision date: 1994-11-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plymouth, MN, US

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Adverse events under product code DQO

product code DQO

Death: 35
Injury: 993
Malfunction: 1,772
Other: 5
Total: 2,805

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.