NORTON CARDIOPLEGIC QUICK COOLING COIL 421738-000— 510(k) K853791

Substantially Equivalent

Norton Performance Plastics Corp.

FDA 510(k) clearance K853791 for NORTON CARDIOPLEGIC QUICK COOLING COIL 421738-000, Substantially Equivalent on 1985-12-09. Applicant: Norton Performance Plastics Corp..

Clearance details

Applicant: Norton Performance Plastics Corp.
Product code: Code DTR
Advisory panel: Cardiovascular
Date received: 1985-09-11
Decision date: 1985-12-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Akron, OH, US

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Adverse events under product code DTR

product code DTR

Other: 1
Total: 1

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.