510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K020028Substantially Equivalent

6F Mach1/34356-Xxx; 5F Mach1/35845-Xxx; 7F Mach1/34357-Xxx; 8F Mach1/34358-Xxx

Boston Scientific Corporation, Maple Grove MN / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K020028 is the FDA 510(k) clearance record for 6F MACH1/34356-XXX; 5F MACH1/35845-XXX; 7F MACH1/34357-XXX; 8F MACH1/34358-XXX, a class II device, cleared for Boston Scientific on under FDA product code DQY (Catheter, Percutaneous). FDA records list 1,110 510(k) clearances for Boston Scientific, from to . As of , FDA records show 11 recalls naming K020028.

Clearance record

Decision date
Received
(18 days to decision)
Product code
DQY Catheter, Percutaneous
Regulation
21 CFR 870.1250
Device class
Class II
Review panel
Cardiovascular
Applicant
Boston Scientific One Scimed Pl., Maple Grove MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DQY

Trailing 12 months
13 clearances under product code DQY in the twelve months to October 2026, July 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code DQY, trailing twelve months
MonthClearances
November 20250
December 20252
January 20260
February 20260
March 20261
April 20262
May 20260
June 20262
July 20263
August 20262
September 20261
October 20260