510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K965247Substantially Equivalent

Envoy Guiding Catheter

Cordis Neurovascular, Inc., Miami Lakes FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K965247 is the FDA 510(k) clearance record for ENVOY GUIDING CATHETER, a class II device, cleared for Cordis Neurovascular, Inc. on under FDA product code DQY (Catheter, Percutaneous). FDA records list 38 510(k) clearances for Cordis Neurovascular, Inc., from to . As of , FDA records show no recalls naming K965247.

Clearance record

Decision date
Received
(211 days to decision)
Product code
DQY Catheter, Percutaneous
Regulation
21 CFR 870.1250
Device class
Class II
Review panel
Cardiovascular
Applicant
Cordis Neurovascular, Inc. 14740 NW 60th Ave., Miami Lakes FL
510(k) summary
Summary
Third party review
No

Clearances, product code DQY

Trailing 12 months
13 clearances under product code DQY in the twelve months to October 2026, July 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code DQY, trailing twelve months
MonthClearances
November 20250
December 20252
January 20260
February 20260
March 20261
April 20262
May 20260
June 20262
July 20263
August 20262
September 20261
October 20260