SCIMED QUEST FLOPPY AND MODERATE SUPPORT GUIDE WIRES— 510(k) K980360

Substantially Equivalent

Scimed Life Systems, Inc.

FDA 510(k) clearance K980360 for SCIMED QUEST FLOPPY AND MODERATE SUPPORT GUIDE WIRES, Substantially Equivalent on 1998-04-29. Applicant: Scimed Life Systems, Inc..

Clearance details

Applicant: Scimed Life Systems, Inc.
Product code: Code DQX
Advisory panel: Cardiovascular
Date received: 1998-01-29
Decision date: 1998-04-29
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.