510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K012948Substantially Equivalent

Modification to Vaxcel Dialysis Catheter

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

K012948 is the FDA 510(k) clearance record for MODIFICATION TO VAXCEL DIALYSIS CATHETER, a class II device, cleared for Boston Scientific/Medi-Tech on under FDA product code MSD (Catheter, Hemodialysis, Implanted). FDA records list 5 510(k) clearances for Boston Scientific/Medi-Tech, from to . As of , FDA records show no recalls naming K012948.

Clearance record

Decision date
Received
(29 days to decision)
Product code
MSD Catheter, Hemodialysis, Implanted
Regulation
21 CFR 876.5540
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Boston Scientific/Medi-Tech One Boston Scientific Pl., Natick, MA
510(k) summary
Summary
Third party review
No

Clearances, product code MSD

Trailing 12 months

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

FDA records show no clearances under product code MSD in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MSD, 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