SCIMED TRANSENT EX STEERABLE GUIDE WIRE AND ACCESSORIES— 510(k) K944677

Substantially Equivalent

Scimed Peripheral Interventions

FDA 510(k) clearance K944677 for SCIMED TRANSENT EX STEERABLE GUIDE WIRE AND ACCESSORIES, Substantially Equivalent on 1995-02-08. Applicant: Scimed Peripheral Interventions.

Clearance details

Applicant: Scimed Peripheral Interventions
Product code: Code DQX
Advisory panel: Cardiovascular
Date received: 1994-09-22
Decision date: 1995-02-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Maple Grove, MN, US

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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.