Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K062852
Device Classification Name
Introducer, Catheter
More FDA Info for this Device
510(K) Number
K062852
Device Name
Introducer, Catheter
Applicant
ONSET MEDICAL CORPORATION
27001 LA PAZ SUITE 312
MISSION VIEJO, CA 92691 US
Other 510(k) Applications for this Company
Contact
ALBERT REGO
Other 510(k) Applications for this Contact
Regulation Number
870.1340
More FDA Info for this Regulation Number
Classification Product Code
DYB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/25/2006
Decision Date
02/23/2007
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