Atlas FDA

UROMAX ULTRA BALLOON DILATATION CATHETER

FDA 510(k) clearance K130804 · decided 2013-05-22

Clearance details

K-number
K130804
Device name
UROMAX ULTRA BALLOON DILATATION CATHETER
Applicant
Boston Scientific Corporation
Decision
Substantially Equivalent
Date received
2013-03-25
Decision date
2013-05-22
Days to decision
58 days
Clearance type
Traditional
Product code
EZN
Device class
2
Regulation number
876.5470
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Marlboro, MA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Boston Scientific UroMax Ultra Kit, Material Numbers (UPN): 1. M0062251200, 2. M0062251210 recall (Z-2536-2025)Boston Scientific Corporation2025-09-05

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