510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K020012Substantially Equivalent

Modification to Renegade Fiber Braided Microcatheter

Boston Scientific/Medi-Tech, Natick, MA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K020012 is the FDA 510(k) clearance record for MODIFICATION TO RENEGADE FIBER BRAIDED MICROCATHETER, a class II device, cleared for Boston Scientific/Medi-Tech on under FDA product code DQO (Catheter, Intravascular, Diagnostic). FDA records list 5 510(k) clearances for Boston Scientific/Medi-Tech, from to . As of , FDA records show one recall naming K020012.

Clearance record

Decision date
Received
(26 days to decision)
Product code
DQO Catheter, Intravascular, Diagnostic
Regulation
21 CFR 870.1200
Device class
Class II
Review panel
Cardiovascular
Applicant
Boston Scientific/Medi-Tech One Boston Scientific Pl., Natick, MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DQO

Trailing 12 months
3 clearances under product code DQO in the twelve months to October 2026, March 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DQO, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20260
May 20261
June 20261
July 20260
August 20260
September 20260
October 20260