510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K010853Substantially Equivalent

Guider Softip Guiding Catheter Xf 5F

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

K010853 is the FDA 510(k) clearance record for GUIDER SOFTIP GUIDING CATHETER XF 5F, a class II device, cleared for Boston Scientific, Target on under FDA product code DQY (Catheter, Percutaneous). FDA records list 1,110 510(k) clearances for Boston Scientific Corporation, from to . As of , FDA records show 17 recalls naming K010853.

Clearance record

Decision date
Received
(28 days to decision)
Product code
DQY Catheter, Percutaneous
Regulation
21 CFR 870.1250
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 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