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
K960923Substantially Equivalent

Carbomedics Mitral Rotator

Carbomedics, Inc., Austin TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K960923 is the FDA 510(k) clearance record for CARBOMEDICS MITRAL ROTATOR, a class I device, cleared for Carbomedics, Inc. on under FDA product code MOP (Rotator, Prosthetic Heart Valve). FDA records list 22 510(k) clearances for Carbomedics, Inc., from to . As of , FDA records show no recalls naming K960923.

Clearance record

Decision date
Received
(54 days to decision)
Product code
MOP Rotator, Prosthetic Heart Valve
Regulation
21 CFR 870.3935
Device class
Class I
Review panel
Cardiovascular
Applicant
Carbomedics, Inc. 1300-C E. Anderson Ln., Austin TX
510(k) summary
Summary
Third party review
No

Clearances, product code MOP

Trailing 12 months

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

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