COBE SMARXT VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR— 510(k) K002591

Substantially Equivalent

Cobe Cardiovascular, Inc.

FDA 510(k) clearance K002591 for COBE SMARXT VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR, Substantially Equivalent on 2000-09-13. Applicant: Cobe Cardiovascular, Inc.. Device class: 2.

Clearance details

Applicant
Cobe Cardiovascular, Inc.
Product code
Code DTP
Device class
Class 2
Regulation
21 CFR 870.4230
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Arvada, CO, US
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