510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K904475Substantially Equivalent

Entree Sheath Introducer System

Cordis US Corp., Miami FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K904475 is the FDA 510(k) clearance record for ENTREE SHEATH INTRODUCER SYSTEM, a class II device, cleared for Cordis Corp. on under FDA product code DYB (Introducer, Catheter). FDA records list 332 510(k) clearances for Cordis US Corp., from to . As of , FDA records show no recalls naming K904475.

Clearance record

Decision date
Received
(182 days to decision)
Product code
DYB Introducer, Catheter
Regulation
21 CFR 870.1340
Device class
Class II
Review panel
Cardiovascular
Applicant
Cordis Corp. P.O. Box 025700, Miami FL
Third party review
No

Clearances, product code DYB

Trailing 12 months
19 clearances under product code DYB in the twelve months to November 2026, April 2026 the highest month at 7.
Show the numbers
Monthly 510(k) clearances under FDA product code DYB, trailing twelve months
MonthClearances
December 20252
January 20261
February 20262
March 20261
April 20267
May 20260
June 20263
July 20262
August 20260
September 20260
October 20261
November 20260