510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K003964Substantially Equivalent

Trapease Permanent Vena Filter and Introduction Kit, Models 466-P306a and 466-P306b

Cordis US Corp., Warren NJ / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K003964 is the FDA 510(k) clearance record for TRAPEASE PERMANENT VENA FILTER AND INTRODUCTION KIT, MODELS 466-P306A AND 466-P306B, a class II device, cleared for Cordis Corp. on under FDA product code DTK (Filter, Intravascular, Cardiovascular). FDA records list 332 510(k) clearances for Cordis US Corp., from to . As of , FDA records show no recalls naming K003964.

Clearance record

Decision date
Received
(28 days to decision)
Product code
DTK Filter, Intravascular, Cardiovascular
Regulation
21 CFR 870.3375
Device class
Class II
Review panel
Cardiovascular
Applicant
Cordis Corp. 7 Powderhorn Dr., Warren NJ
510(k) summary
Summary
Third party review
No

Clearances, product code DTK

Trailing 12 months

FDA records hold no clearances under product code DTK in the trailing twelve months.

FDA records show no clearances under product code DTK in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DTK, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260