510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K004046Substantially Equivalent

Cobe Vvr 4000 Filtered Hardshell Venous Reservoir, Cobe Smarxt Vvr 4000 Filtered Hardshell Venous Reservoir

LivaNova USA, Inc., Arvada CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K004046 is the FDA 510(k) clearance record for COBE VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR, COBE SMARXT VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR, a class II device, cleared for Cobe Cardiovascular, Inc. on under FDA product code DTP (Defoamer, Cardiopulmonary Bypass). FDA records list 49 510(k) clearances for LivaNova USA, INC., from to . As of , FDA records show no recalls naming K004046.

Clearance record

Decision date
Received
(118 days to decision)
Product code
DTP Defoamer, Cardiopulmonary Bypass
Regulation
21 CFR 870.4230
Device class
Class II
Review panel
Cardiovascular
Applicant
Cobe Cardiovascular, Inc. 14401 W. 65th Way, Arvada CO
510(k) summary
Summary
Third party review
No

Clearances, product code DTP

Trailing 12 months

FDA records hold no clearances under product code DTP in the trailing twelve months.

FDA records show no clearances under product code DTP in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DTP, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260