BIOPATCH BOVINE PERICARDIAL PATCH— 510(k) K840756

Substantially Equivalent

Meadox Medicals, Div. Boston Scientific Corp.

FDA 510(k) clearance K840756 for BIOPATCH BOVINE PERICARDIAL PATCH, Substantially Equivalent on 1985-02-08. Applicant: Meadox Medicals, Div. Boston Scientific Corp..

Clearance details

Applicant: Meadox Medicals, Div. Boston Scientific Corp.
Product code: Code DQX
Advisory panel: Cardiovascular
Date received: 1984-02-23
Decision date: 1985-02-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oakland, NJ, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DQX

product code DQX

Death: 298
Injury: 4,385
Malfunction: 7,203
Other: 5
Total: 11,891

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.