510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K933020Substantially Equivalent

Mod. Phantom 5 Plus Urol. Balloon Dilation Catheter

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

K933020 is the FDA 510(k) clearance record for MOD. PHANTOM 5 PLUS UROL. BALLOON DILATION CATHETER, a class II device, cleared for Boston Scientific Corp on under FDA product code EYB (Catheter, Ureteral, Gastro-Urology). FDA records list 1,110 510(k) clearances for Boston Scientific Corp, from to . As of , FDA records show no recalls naming K933020.

Clearance record

Decision date
Received
(195 days to decision)
Product code
EYB Catheter, Ureteral, Gastro-Urology
Regulation
21 CFR 876.5130
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Boston Scientific Corp 2710 Orchard Pkwy., San Jose CA
510(k) summary
Summary
Third party review
No

Clearances, product code EYB

Trailing 12 months

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

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