510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K192370Substantially Equivalent

MEDRAD Stellant FLEX CT Injection System with Certegra Workstation

Medrad, Inc., Whippany NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K192370 is the FDA 510(k) clearance record for MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, a class II device, cleared for Bayer Medical Care, Inc. on under FDA product code DXT (Injector And Syringe, Angiographic). FDA records list 177 510(k) clearances for Medrad, Inc., from to . As of , FDA records show one recall naming K192370.

Clearance record

Decision date
Received
(105 days to decision)
Product code
DXT Injector And Syringe, Angiographic
Regulation
21 CFR 870.1650
Device class
Class II
Review panel
Cardiovascular
Applicant
Bayer Medical Care, Inc. 100 Bayer Blvd., Whippany NJ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DXT

Trailing 12 months
6 clearances under product code DXT in the twelve months to October 2026, May 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code DXT, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20261
March 20261
April 20261
May 20263
June 20260
July 20260
August 20260
September 20260
October 20260