VASCULAR GRAFT PROSTHESIS EXPANDED MICR— 510(k) K830543

Substantially Equivalent

Impra, Inc.

FDA 510(k) clearance K830543 for VASCULAR GRAFT PROSTHESIS EXPANDED MICR, Substantially Equivalent on 1983-07-19. Applicant: Impra, Inc..

Clearance details

Applicant: Impra, Inc.
Product code: Code DSY
Advisory panel: Cardiovascular
Date received: 1983-02-22
Decision date: 1983-07-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DSY

product code DSY

Death: 29
Injury: 694
Total: 723

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.