510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K011835Substantially Equivalent

Cobe Revolution

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

K011835 is the FDA 510(k) clearance record for COBE REVOLUTION, a class II device, cleared for Cobe Cardiovascular, Inc. on under FDA product code KFM (Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type). FDA records list 49 510(k) clearances for LivaNova USA, INC., from to . As of , FDA records show one recall naming K011835.

Clearance record

Decision date
Received
(245 days to decision)
Product code
KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Regulation
21 CFR 870.4360
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 KFM

Trailing 12 months

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

FDA records show no clearances under product code KFM in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KFM, 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