INTRAVASCULAR GUIDE WIRE AND EXTENSION WIRE— 510(k) K924009

Substantially Equivalent

Pilot Cardiovascular Systems, Inc., Sub. C.R. Bard

FDA 510(k) clearance K924009 for INTRAVASCULAR GUIDE WIRE AND EXTENSION WIRE, Substantially Equivalent on 1992-11-06. Applicant: Pilot Cardiovascular Systems, Inc., Sub. C.R. Bard.

Clearance details

Applicant: Pilot Cardiovascular Systems, Inc., Sub. C.R. Bard
Product code: Code DQX
Advisory panel: Cardiovascular
Date received: 1992-08-10
Decision date: 1992-11-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Clemente, CA, 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.