510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K130366Substantially Equivalent

Bard Denali Filter System- Femoral Delivery Kit and Jugular Delivery Kit

C.R. Bard Inc, Tempe AZ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K130366 is the FDA 510(k) clearance record for BARD DENALI FILTER SYSTEM- FEMORAL DELIVERY KIT AND JUGULAR DELIVERY KIT, a class II device, cleared for C.R. Bard, Inc. on under FDA product code DTK (Filter, Intravascular, Cardiovascular). FDA records list 646 510(k) clearances for C.R. Bard, Inc., from to . As of , FDA records show 3 recalls naming K130366.

Clearance record

Decision date
Received
(91 days to decision)
Product code
DTK Filter, Intravascular, Cardiovascular
Regulation
21 CFR 870.3375
Device class
Class II
Review panel
Cardiovascular
Applicant
C.R. Bard, Inc. 1625 W. 3rd St., Tempe AZ
510(k) summary
Summary PDF
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