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

Name: FDA 510(k) clearance K924009
Creator: U.S. Food and Drug Administration
Published: 1992-11-06

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. Device class: 2.

Clearance details

Applicant: Pilot Cardiovascular Systems, Inc., Sub. C.R. Bard
Product code: Code DQX
Device class: Class 2
Regulation: 21 CFR 870.1330
Advisory panel: Cardiovascular
Date received: 1992-08-10
Decision date: 1992-11-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Clemente, CA, US

Download summary PDF View on FDA.gov ↗

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K934474 — PILOT CARDIOVASCULAR SYSTEMS 2 CM PILOT WIRE1993-11-08

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.