Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K201760
Device Classification Name
Wire, Guide, Catheter
More FDA Info for this Device
510(K) Number
K201760
Device Name
Wire, Guide, Catheter
Applicant
Scientia Vascular LLC
3487 West 2100 South Suite 100
West Valley City, UT 84119 US
Other 510(k) Applications for this Company
Contact
Amy McManus
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
06/29/2020
Decision Date
07/29/2020
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact