FEMORAL ANGIOGRAPHY DRAPE— 510(k) K896088

Substantially Equivalent

Medical Plastics, Inc.

FDA 510(k) clearance K896088 for FEMORAL ANGIOGRAPHY DRAPE, Substantially Equivalent on 1989-11-17. Applicant: Medical Plastics, Inc..

Clearance details

Applicant: Medical Plastics, Inc.
Product code: Code IZI
Advisory panel: Radiology
Date received: 1989-10-19
Decision date: 1989-11-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Roswell, GA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code IZI

product code IZI

Death: 9
Malfunction: 5,312
Total: 5,321

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.