510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K990396Substantially Equivalent

T-Anastaflo

Edwards Lifesciences LLC, Midvale UT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K990396 is the FDA 510(k) clearance record for T-ANASTAFLO, a class II device, cleared for Edwards Lifesciences Research Medical on under FDA product code DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass). FDA records list 165 510(k) clearances for EDWARDS LIFESCIENCES LLC, from to . As of , FDA records show one recall naming K990396.

Clearance record

Decision date
Received
(234 days to decision)
Product code
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Regulation
21 CFR 870.4210
Device class
Class II
Review panel
Cardiovascular
Applicant
Edwards Lifesciences Research Medical 6864 S. 300 W., Midvale UT
510(k) summary
Summary
Third party review
No

Clearances, product code DWF

Trailing 12 months
8 clearances under product code DWF in the twelve months to October 2026, January 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code DWF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20262
February 20262
March 20261
April 20261
May 20260
June 20260
July 20260
August 20260
September 20261
October 20261