510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K201057Substantially Equivalent

Bio-Medicus Life Support Catheter and Introducer

Medtronic, Inc., Mounds View MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K201057 is the FDA 510(k) clearance record for Bio-Medicus Life Support Catheter and Introducer, a class II device, cleared for Medtronic, Inc. on under FDA product code QHW (Single Lumen Ecmo Cannula). FDA's definition for product code QHW reads: "Single-lumen cannulas/catheters to be used with an extracorporeal circuit intended for use in patients with acute respiratory failure or acute cardiopulmonary failure, where other available treatment options have failed, and continued...". FDA records list 1,525 510(k) clearances for Medtronic, Inc., from to . As of , FDA records show no recalls naming K201057.

Clearance record

Decision date
Received
(633 days to decision)
Product code
QHW Single Lumen Ecmo Cannula
Regulation
21 CFR 870.4100
Device class
Class II
Review panel
Cardiovascular
Applicant
Medtronic, Inc. 8200 Coral Sea St. N.E, Mounds View MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QHW

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