Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K232570
Device Classification Name
Wire, Guide, Catheter
More FDA Info for this Device
510(K) Number
K232570
Device Name
Wire, Guide, Catheter
Applicant
Medtronic Vascular
3850 Brickway Blvd.
Santa Rosa, CA 95403 US
Other 510(k) Applications for this Company
Contact
Amy Sanders
Other 510(k) Applications for this Contact
Regulation Number
870.1330
More FDA Info for this Regulation Number
Classification Product Code
DQX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/24/2023
Decision Date
10/24/2023
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
FDA Source Information for K232570
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact