Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K191609
Device Classification Name
Stent, Ureteral
More FDA Info for this Device
510(K) Number
K191609
Device Name
Stent, Ureteral
Applicant
Boston Scientific Corporation
100 Boston Scientific Way
Marlborough, MA 01752 US
Other 510(k) Applications for this Company
Contact
Justin Kapitan
Other 510(k) Applications for this Contact
Regulation Number
876.4620
More FDA Info for this Regulation Number
Classification Product Code
FAD
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/17/2019
Decision Date
08/16/2019
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact