510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K970375Substantially Equivalent - Subject to Tracking Reg.

Annuloflo System

Carbomedics, Inc., Austin TX / Traditional, Substantially Equivalent - Subject to Tracking Reg.
FDA source (opens on fda.gov)

K970375 is the FDA 510(k) clearance record for ANNULOFLO SYSTEM, a class II device, cleared for Carbomedics, Inc. on under FDA product code KRH (Ring, Annuloplasty). FDA records list 22 510(k) clearances for Carbomedics, Inc., from to . As of , FDA records show no recalls naming K970375.

Clearance record

Decision date
Received
(172 days to decision)
Product code
KRH Ring, Annuloplasty
Regulation
21 CFR 870.3800
Device class
Class II
Review panel
Cardiovascular
Applicant
Carbomedics, Inc. 1300 E. Anderson Ln., Austin TX
Third party review
No

Clearances, product code KRH

Trailing 12 months
2 clearances under product code KRH in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code KRH, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20261
July 20260
August 20260
September 20260
October 20260