CUSTOM CORONARY MANIFOLD KITS— 510(k) K853749

Substantially Equivalent

Procedure Products, Inc.

FDA 510(k) clearance K853749 for CUSTOM CORONARY MANIFOLD KITS, Substantially Equivalent on 1986-01-13. Applicant: Procedure Products, Inc..

Clearance details

Applicant: Procedure Products, Inc.
Product code: Code DTL
Advisory panel: Cardiovascular
Date received: 1985-09-09
Decision date: 1986-01-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Vancouver, WA, US

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Adverse events under product code DTL

product code DTL

Malfunction: 770
Total: 770

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.