Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K200257
Device Classification Name
Stent, Colonic, Metalic, Expandable
More FDA Info for this Device
510(K) Number
K200257
Device Name
Stent, Colonic, Metalic, Expandable
Applicant
Boston Scientific Corporation
100 Boston Scientific Way
Marlborough, MA 01752 US
Other 510(k) Applications for this Company
Contact
Catherine Sanford
Other 510(k) Applications for this Contact
Regulation Number
878.3610
More FDA Info for this Regulation Number
Classification Product Code
MQR
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/03/2020
Decision Date
04/17/2020
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
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