510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K991986Substantially Equivalent

Cobe Brat 2 Autologous Blood Salvage System with the Crit-Line Hematocrit Sampling System Option

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

K991986 is the FDA 510(k) clearance record for COBE BRAT 2 AUTOLOGOUS BLOOD SALVAGE SYSTEM WITH THE CRIT-LINE HEMATOCRIT SAMPLING SYSTEM OPTION, a class II device, cleared for Cobe Cardiovascular, Inc. on under FDA product code CAC (Apparatus, Autotransfusion). FDA records list 49 510(k) clearances for LivaNova USA, INC., from to . As of , FDA records show no recalls naming K991986.

Clearance record

Decision date
Received
(87 days to decision)
Product code
CAC Apparatus, Autotransfusion
Regulation
21 CFR 868.5830
Device class
Class II
Review panel
Anesthesiology
Applicant
Cobe Cardiovascular, Inc. 14401 W. 65th Way, Arvada CO
510(k) summary
Summary
Third party review
No

Clearances, product code CAC

Trailing 12 months

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

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