510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K010485Substantially Equivalent

Vena Tech Vena Cava Filter; Vena Tech 30D Vena Cava Filter; Vena Tech Lp Cave Filter

Bbraun, Evanston IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K010485 is the FDA 510(k) clearance record for VENA TECH VENA CAVA FILTER; VENA TECH 30D VENA CAVA FILTER; VENA TECH LP CAVE FILTER, a class II device, cleared for Bbraun on under FDA product code DTK (Filter, Intravascular, Cardiovascular). FDA records list one 510(k) clearance for Bbraun. As of , FDA records show one recall naming K010485.

Clearance record

Decision date
Received
(87 days to decision)
Product code
DTK Filter, Intravascular, Cardiovascular
Regulation
21 CFR 870.3375
Device class
Class II
Review panel
Cardiovascular
Applicant
Bbraun 2934 Central St., Suite 1a, Evanston IL
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