Atlas FDA

Tria Firm Ureteral Stent

FDA 510(k) clearance K190603 · decided 2019-05-24

Clearance details

K-number
K190603
Device name
Tria Firm Ureteral Stent
Applicant
Boston Scientific Corporation
Decision
Substantially Equivalent
Date received
2019-03-08
Decision date
2019-05-24
Days to decision
77 days
Clearance type
Special
Product code
FAD
Device class
2
Regulation number
876.4620
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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