510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K860775Substantially Equivalent

Mediastinal Autotransfusion System

Cardio Metrics, Inc., Houston TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K860775 is the FDA 510(k) clearance record for MEDIASTINAL AUTOTRANSFUSION SYSTEM, a class II device, cleared for Cardio Metrics, Inc. on under FDA product code DTP (Defoamer, Cardiopulmonary Bypass). FDA records list 23 510(k) clearances for Cardio Metrics, Inc., from to . As of , FDA records show no recalls naming K860775.

Clearance record

Decision date
Received
(86 days to decision)
Product code
DTP Defoamer, Cardiopulmonary Bypass
Regulation
21 CFR 870.4230
Device class
Class II
Review panel
Cardiovascular
Applicant
Cardio Metrics, Inc. 10415 Landsbury Dr., Houston TX
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