510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K904788Substantially Equivalent

Mewissen Catheter

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

K904788 is the FDA 510(k) clearance record for MEWISSEN CATHETER, a class II device, cleared for Boston Scientific Corp on under FDA product code DQO (Catheter, Intravascular, Diagnostic). FDA records list 1,110 510(k) clearances for Boston Scientific Corp, from to . As of , FDA records show no recalls naming K904788.

Clearance record

Decision date
Received
(55 days to decision)
Product code
DQO Catheter, Intravascular, Diagnostic
Regulation
21 CFR 870.1200
Device class
Class II
Review panel
Cardiovascular
Applicant
Boston Scientific Corp 2710 Orchard Pkwy., San Jose CA
Third party review
No

Clearances, product code DQO

Trailing 12 months
3 clearances under product code DQO in the twelve months to November 2026, March 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DQO, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20261
April 20260
May 20261
June 20261
July 20260
August 20260
September 20260
October 20260
November 20260