Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K131144
Device Classification Name
Introducer, Catheter
More FDA Info for this Device
510(K) Number
K131144
Device Name
Introducer, Catheter
Applicant
AMECO MEDICAL INDUSTRIES
57 LAZY BROOK RD
MONROE, CT 06468 US
Other 510(k) Applications for this Company
Contact
RAYMOND J KELLY
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
04/23/2013
Decision Date
08/15/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact