SCIMED CARDIOTHERM CARDIOPLEGIA DELIVERY SYSTEM— 510(k) K904171

Substantially Equivalent

Scimed

FDA 510(k) clearance K904171 for SCIMED CARDIOTHERM CARDIOPLEGIA DELIVERY SYSTEM, Substantially Equivalent on 1990-12-06. Applicant: Scimed.

Clearance details

Applicant: Scimed
Product code: Code DTR
Advisory panel: Cardiovascular
Date received: 1990-09-11
Decision date: 1990-12-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, 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.