Atlas FDA

OCCLUDER OCCLUSION BALLOON CATHETER

FDA 510(k) clearance K133750 · decided 2014-01-08

Clearance details

K-number
K133750
Device name
OCCLUDER OCCLUSION BALLOON CATHETER
Applicant
Boston Scientific Corporation
Decision
Substantially Equivalent
Date received
2013-12-09
Decision date
2014-01-08
Days to decision
30 days
Clearance type
Traditional
Product code
EYB
Device class
2
Regulation number
876.5130
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

No recalls on record reference this clearance.

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