SCIMED ENTRE PTCA GUIDE WIRE AND RENDEZVOUS PTCA— 510(k) K923480

Substantially Equivalent

Scimed Life Systems, Inc.

FDA 510(k) clearance K923480 for SCIMED ENTRE PTCA GUIDE WIRE AND RENDEZVOUS PTCA, Substantially Equivalent on 1992-10-06. Applicant: Scimed Life Systems, Inc..

Clearance details

Applicant: Scimed Life Systems, Inc.
Product code: Code DQO
Advisory panel: Cardiovascular
Date received: 1992-07-15
Decision date: 1992-10-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Maple Grove, 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.