Atlas FDA

Imager II Urology Torque Catheter

FDA 510(k) clearance K180530 · decided 2018-04-10

Clearance details

K-number
K180530
Device name
Imager II Urology Torque Catheter
Applicant
Boston Scientific Corporation
Decision
Substantially Equivalent
Date received
2018-02-28
Decision date
2018-04-10
Days to decision
41 days
Clearance type
Special
Product code
KOD
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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