510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K823451Substantially Equivalent

Clear Cardioplejia Delivery System

3M Health Care, Sarns, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K823451 is the FDA 510(k) clearance record for CLEAR CARDIOPLEJIA DELIVERY SYSTEM, a class II device, cleared for 3M Health Care, Sarns on under FDA product code DTR (Heat-Exchanger, Cardiopulmonary Bypass). FDA records list 76 510(k) clearances for 3M Health Care, Sarns, from to . As of , FDA records show 14 recalls naming K823451.

Clearance record

Decision date
Received
(58 days to decision)
Product code
DTR Heat-Exchanger, Cardiopulmonary Bypass
Regulation
21 CFR 870.4240
Device class
Class II
Review panel
Cardiovascular
Applicant
3M Health Care, Sarns 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code DTR

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