510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K940489Substantially Equivalent

Simon Nitinol Filter

Nitinol Medical Technologies, Inc., Boston MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K940489 is the FDA 510(k) clearance record for SIMON NITINOL FILTER, a class II device, cleared for Nitinol Medical Technologies, Inc. on under FDA product code DTK (Filter, Intravascular, Cardiovascular). FDA records list 7 510(k) clearances for Nitinol Medical Technologies, Inc., from to . As of , FDA records show no recalls naming K940489.

Clearance record

Decision date
Received
(196 days to decision)
Product code
DTK Filter, Intravascular, Cardiovascular
Regulation
21 CFR 870.3375
Device class
Class II
Review panel
Cardiovascular
Applicant
Nitinol Medical Technologies, Inc. 374 Congress St., Suite 605, Boston MA
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