HUNTER 0.014 INCH SUPER SOFT / HUNTER O.014 INCH SOFT GUIDE WIRES W/THROMBORESISTANT PC COATING— 510(k) K970938

Name: FDA 510(k) clearance K970938
Creator: U.S. Food and Drug Administration
Published: 1997-11-17

Substantially Equivalent

Biocompatibles Cardiovascular, Inc.

FDA 510(k) clearance K970938 for HUNTER 0.014 INCH SUPER SOFT / HUNTER O.014 INCH SOFT GUIDE WIRES W/THROMBORESISTANT PC COATING, Substantially Equivalent on 1997-11-17. Applicant: Biocompatibles Cardiovascular, Inc.. Device class: 2.

Clearance details

Applicant: Biocompatibles Cardiovascular, Inc.
Product code: Code DQX
Device class: Class 2
Regulation: 21 CFR 870.1330
Advisory panel: Cardiovascular
Date received: 1997-03-13
Decision date: 1997-11-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockville, MD, US

Download summary PDF View on FDA.gov ↗

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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.