VALVE, PRESSURE RELIEF, BLOOD OXYGENATOR— 510(k) K770681

Substantially Equivalent

Scimed Life Systems, Inc.

FDA 510(k) clearance K770681 for VALVE, PRESSURE RELIEF, BLOOD OXYGENATOR, Substantially Equivalent on 1977-04-26. Applicant: Scimed Life Systems, Inc.. Device class: 1.

Clearance details

Applicant
Scimed Life Systems, Inc.
Product code
Code KRI
Device class
Class 1
Regulation
21 CFR 870.4200
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mchenry, IL, US
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