Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K955230
Device Classification Name
Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
More FDA Info for this Device
510(K) Number
K955230
Device Name
Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Applicant
VASCUTEK LTD.
1300 EAST ANDERSON LN.
AUSTIN, TX 78752 US
Other 510(k) Applications for this Company
Contact
TEENA M AUGOSTINO
Other 510(k) Applications for this Contact
Regulation Number
870.3450
More FDA Info for this Regulation Number
Classification Product Code
DSY
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/14/1995
Decision Date
02/09/1996
Decision
ST - Substantially Equivalent - Subject to Tracking Reg.
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact