510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K013866Substantially Equivalent

Convoy Advanced Delivery Sheath Kit

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

K013866 is the FDA 510(k) clearance record for CONVOY ADVANCED DELIVERY SHEATH KIT, a class I device, cleared for Boston Scientific on under FDA product code DBY (Fab, Rhodamine, Antigen, Antiserum, Control). FDA records list 1,110 510(k) clearances for Boston Scientific, from to . As of , FDA records show 2 recalls naming K013866.

Clearance record

Decision date
Received
(23 days to decision)
Product code
DBY Fab, Rhodamine, Antigen, Antiserum, Control
Regulation
21 CFR 866.5520
Device class
Class I
Review panel
Immunology
Applicant
Boston Scientific 2710 Orchard Pkwy., San Jose CA
510(k) summary
Summary
Third party review
No

Clearances, product code DBY

Trailing 12 months

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

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