510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K973472Substantially Equivalent

3M Cdi H/s Cuvettes with Heparon Treatment

3M Healthcare, Tistin CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K973472 is the FDA 510(k) clearance record for 3M CDI H/S CUVETTES WITH HEPARON TREATMENT, a class II device, cleared for 3M Healthcare on under FDA product code DRY (Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass). FDA records list 21 510(k) clearances for 3M Healthcare, from to . As of , FDA records show no recalls naming K973472.

Clearance record

Decision date
Received
(87 days to decision)
Product code
DRY Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
Regulation
21 CFR 870.4330
Device class
Class II
Review panel
Cardiovascular
Applicant
3M Healthcare 1311 Valencia Ave., Tistin CA
510(k) summary
Summary
Third party review
No

Clearances, product code DRY

Trailing 12 months

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

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