Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K230263
Device Classification Name
Catheter, Angioplasty, Peripheral, Transluminal
More FDA Info for this Device
510(K) Number
K230263
Device Name
Catheter, Angioplasty, Peripheral, Transluminal
Applicant
Summa Therapeutics, LLC
225 Dyer Street, 2nd Floor
Providence, RI 02903 US
Other 510(k) Applications for this Company
Contact
Timothy Murphy
Other 510(k) Applications for this Contact
Regulation Number
870.1250
More FDA Info for this Regulation Number
Classification Product Code
LIT
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/31/2023
Decision Date
05/26/2023
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact