6 FRENCH, 7 FRENCH, AND 8 FRENCH GUIDING CATHETERS WITH PHOSPHORYLCHOLINE (PC) POLYMER COATING— 510(k) K962717

Substantially Equivalent

Biocompatibles Cardiovascular, Inc.

FDA 510(k) clearance K962717 for 6 FRENCH, 7 FRENCH, AND 8 FRENCH GUIDING CATHETERS WITH PHOSPHORYLCHOLINE (PC) POLYMER COATING, Substantially Equivalent on 1997-02-12. Applicant: Biocompatibles Cardiovascular, Inc..

Clearance details

Applicant: Biocompatibles Cardiovascular, Inc.
Product code: Code DQY
Advisory panel: Cardiovascular
Date received: 1996-07-12
Decision date: 1997-02-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockville, MD, US

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Adverse events under product code DQY

product code DQY

Death: 464
Injury: 4,489
Malfunction: 13,721
Other: 2
Total: 18,676

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.