510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K234118Substantially Equivalent

CentriMag™ Acute Circulatory Support System

Abbott Medical, Pleasanton CA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K234118 is the FDA 510(k) clearance record for CentriMag™ Acute Circulatory Support System, a class II device, cleared for ABBOTT MEDICAL 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 1,478 510(k) clearances for ABBOTT MEDICAL, from to . As of , FDA records show no recalls naming K234118.

Clearance record

Decision date
Received
(29 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
Abbott Medical 6035 Stoneridge Dr. Pleasanton, Pleasanton CA
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