CVI 8.5 FRENCH PERCUTANEOUS SHEATH INTRODUCER SYS.— 510(k) K863917

Substantially Equivalent

Cardio-Vascular Innovations, Inc.

FDA 510(k) clearance K863917 for CVI 8.5 FRENCH PERCUTANEOUS SHEATH INTRODUCER SYS., Substantially Equivalent on 1987-01-06. Applicant: Cardio-Vascular Innovations, Inc..

Clearance details

Applicant: Cardio-Vascular Innovations, Inc.
Product code: Code DYB
Advisory panel: Cardiovascular
Date received: 1986-10-08
Decision date: 1987-01-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chantilly, VA, US

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Adverse events under product code DYB

product code DYB

Death: 808
Injury: 5,922
Malfunction: 16,516
Other: 5
Total: 23,251

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.