510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K932921Substantially Equivalent

Percutaneous Introducer for Vena Cava Filter Syst

B. Braun Vena-Tech, Evanston IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K932921 is the FDA 510(k) clearance record for PERCUTANEOUS INTRODUCER FOR VENA CAVA FILTER SYST, a class II device, cleared for B. Braun Vena-Tech on under FDA product code DTK (Filter, Intravascular, Cardiovascular). FDA records list 2 510(k) clearances for B. Braun Vena-Tech, from to . As of , FDA records show no recalls naming K932921.

Clearance record

Decision date
Received
(76 days to decision)
Product code
DTK Filter, Intravascular, Cardiovascular
Regulation
21 CFR 870.3375
Device class
Class II
Review panel
Cardiovascular
Applicant
B. Braun Vena-Tech Northwestern Univ. Rese. Park, 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