510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K120402Substantially Equivalent

Crux Vena Cava Filter System

Crux Biomedical, Menlo Park CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K120402 is the FDA 510(k) clearance record for CRUX VENA CAVA FILTER SYSTEM, a class II device, cleared for Crux Biomedical on under FDA product code DTK (Filter, Intravascular, Cardiovascular). FDA records list 2 510(k) clearances for Crux Biomedical, from to . As of , FDA records show no recalls naming K120402.

Clearance record

Decision date
Received
(156 days to decision)
Product code
DTK Filter, Intravascular, Cardiovascular
Regulation
21 CFR 870.3375
Device class
Class II
Review panel
Cardiovascular
Applicant
Crux Biomedical 1455 Adams Dr., #1170, Menlo Park CA
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