PERI-GUARD, CV PERI-GUARD, OCU-GUARD, SUPPLE PERI-GUARD, PERI-STRIPS - SLEEVE, PERI-STRIPS-STRIPS, PERI-STRIPS DRY, VASC— 510(k) K983162

Substantially Equivalent

Bio-Vascular, Inc.

FDA 510(k) clearance K983162 for PERI-GUARD, CV PERI-GUARD, OCU-GUARD, SUPPLE PERI-GUARD, PERI-STRIPS - SLEEVE, PERI-STRIPS-STRIPS, PERI-STRIPS DRY, VASC, Substantially Equivalent on 1998-10-09. Applicant: Bio-Vascular, Inc..

Clearance details

Applicant: Bio-Vascular, Inc.
Product code: Code FTM
Advisory panel: General, Plastic Surgery
Date received: 1998-09-10
Decision date: 1998-10-09
Decision: Substantially Equivalent
Clearance type: Special
Location: St. Paul, MN, US

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Adverse events under product code FTM

product code FTM

Death: 17
Injury: 2,174
Total: 2,191

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.