510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K011906Substantially Equivalent

Back-Up Meier Guidewire

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

K011906 is the FDA 510(k) clearance record for BACK-UP MEIER GUIDEWIRE, a class II device, cleared for Boston Scientific Corp on under FDA product code DQX (Wire, Guide, Catheter). FDA records list 1,110 510(k) clearances for Boston Scientific Corp, from to . As of , FDA records show one recall naming K011906.

Clearance record

Decision date
Received
(55 days to decision)
Product code
DQX Wire, Guide, Catheter
Regulation
21 CFR 870.1330
Device class
Class II
Review panel
Cardiovascular
Applicant
Boston Scientific Corp One Boston Scientific Pl., Natick, MA
510(k) summary
Summary
Third party review
No

Clearances, product code DQX

Trailing 12 months
12 clearances under product code DQX in the twelve months to October 2026, January 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code DQX, trailing twelve months
MonthClearances
November 20251
December 20250
January 20263
February 20260
March 20263
April 20260
May 20261
June 20260
July 20262
August 20260
September 20262
October 20260