MEDTRONIC OVERPRESSURE/VACUUM RELIEF VALVE— 510(k) K953564

Name: FDA 510(k) clearance K953564
Creator: U.S. Food and Drug Administration
Published: 1996-02-02

Substantially Equivalent

Medtronic Cardiac Surgery, Medtronic, Inc.

FDA 510(k) clearance K953564 for MEDTRONIC OVERPRESSURE/VACUUM RELIEF VALVE, Substantially Equivalent on 1996-02-02. Applicant: Medtronic Cardiac Surgery, Medtronic, Inc.. Device class: 2.

Clearance details

Applicant: Medtronic Cardiac Surgery, Medtronic, Inc.
Product code: Code DTL
Device class: Class 2
Regulation: 21 CFR 870.4290
Advisory panel: Cardiovascular
Date received: 1995-07-31
Decision date: 1996-02-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Anaheim, CA, US

Download summary PDF View on FDA.gov ↗

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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.