510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K230364Substantially Equivalent

VitalFlow™ Console

Michigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.), Dexter MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K230364 is the FDA 510(k) clearance record for VitalFlow™ Console, a class II device, cleared for Michigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.) on under FDA product code QNR (Blood Pump For Ecmo, Long-Term (> 6 Hours) Use). FDA's definition for product code QNR reads: "A blood pump for long-term circulatory support is a device intended for use as part of an extracorporeal circuit intended to provide assisted extracorporeal circulation and physiologic gas exchange of the patient's blood in patients with...". FDA records list 2 510(k) clearances for Michigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.). As of , FDA records show one recall naming K230364.

Clearance record

Decision date
Received
(196 days to decision)
Product code
QNR Blood Pump For Ecmo, Long-Term (> 6 Hours) Use
Regulation
21 CFR 870.4100
Device class
Class II
Review panel
Cardiovascular
Applicant
Michigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.) 2555 Bishop Cir. W, Dexter MI
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QNR

Trailing 12 months

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

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