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510(k) K141820

JAGWIRE HIGH PERFORMANCE GUIDWIRE by Boston Scientific Corp — Product Code OCY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 21, 2014
Date Received
July 7, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscopic Guidewire, Gastroenterology-Urology
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

To provide access to gi or gu tract for the purpose of passing or exchanging other accessories.

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