Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K101479
Device Classification Name
Catheter, Percutaneous
More FDA Info for this Device
510(K) Number
K101479
Device Name
Catheter, Percutaneous
Applicant
REFLOW MEDICAL
5311 FOXHOUND WAY
SAN DIEGO, CA 92130 US
Other 510(k) Applications for this Company
Contact
REBECCA PINE
Other 510(k) Applications for this Contact
Regulation Number
870.1250
More FDA Info for this Regulation Number
Classification Product Code
DQY
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/28/2010
Decision Date
08/11/2010
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