510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K822000Substantially Equivalent

Extracorporeal Blood Gas System

Cardiovascular Devices, Inc., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K822000 is the FDA 510(k) clearance record for EXTRACORPOREAL BLOOD GAS SYSTEM, a class II device, cleared for Cardiovascular Devices, Inc. on under FDA product code DTY (Sensor, Blood-Gas, In-Line, Cardiopulmonary Bypass). FDA records list 8 510(k) clearances for Cardiovascular Devices, Inc., from to . As of , FDA records show no recalls naming K822000.

Clearance record

Decision date
Received
(168 days to decision)
Product code
DTY Sensor, Blood-Gas, In-Line, Cardiopulmonary Bypass
Regulation
21 CFR 870.4410
Device class
Class II
Review panel
Cardiovascular
Applicant
Cardiovascular Devices, Inc. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code DTY

Trailing 12 months

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

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