0.014 INCH EXTRA LONG FLOPPY AND 0.014 EXTRA LONG INTERMEDIATE GUIDE WIRES WITH PHOSPHORYLCHOLINE (PC) POLYMER COATING— 510(k) K962266

Name: FDA 510(k) clearance K962266
Creator: U.S. Food and Drug Administration
Published: 1996-09-10

Substantially Equivalent

Biocompatibles Cardiovascular, Inc.

FDA 510(k) clearance K962266 for 0.014 INCH EXTRA LONG FLOPPY AND 0.014 EXTRA LONG INTERMEDIATE GUIDE WIRES WITH PHOSPHORYLCHOLINE (PC) POLYMER COATING, Substantially Equivalent on 1996-09-10. 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: 1996-06-12
Decision date: 1996-09-10
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.