510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K091542Substantially Equivalent

Estech Easyflow Cannula with Guidewire

Endoscopic Technologies, Inc. D/B/A Estech, San Ramon CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K091542 is the FDA 510(k) clearance record for ESTECH EASYFLOW CANNULA WITH GUIDEWIRE, a class II device, cleared for Endoscopic Technologies, Inc. D/B/A Estech on under FDA product code DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass). FDA records list 5 510(k) clearances for Endoscopic Technologies, Inc. D/B/A Estech, from to . As of , FDA records show no recalls naming K091542.

Clearance record

Decision date
Received
(147 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
Endoscopic Technologies, Inc. D/B/A Estech 2603 Camino Ramon, San Ramon CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DWF

Trailing 12 months
6 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 20260
October 20260