510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K014109Substantially Equivalent

In-Time Retrieval Device

Boston Scientific Corporation, Fremont CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K014109 is the FDA 510(k) clearance record for IN-TIME RETRIEVAL DEVICE, a class II device, cleared for Boston Scientific, Target on under FDA product code MMX (Device, Percutaneous Retrieval). FDA records list 1,110 510(k) clearances for Boston Scientific Corporation, from to . As of , FDA records show no recalls naming K014109.

Clearance record

Decision date
Received
(88 days to decision)
Product code
MMX Device, Percutaneous Retrieval
Regulation
21 CFR 870.5150
Device class
Class II
Review panel
Cardiovascular
Applicant
Boston Scientific, Target 47900 Bayside Pkwy., Fremont CA
510(k) summary
Summary
Third party review
No

Clearances, product code MMX

Trailing 12 months

FDA records hold no clearances under product code MMX in the trailing twelve months.

FDA records show no clearances under product code MMX in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MMX, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260