FDA 510(k) Application Details - K110617

Device Classification Name Catheters, Transluminal Coronary Angioplasty, Percutaneous

  More FDA Info for this Device
510(K) Number K110617
Device Name Catheters, Transluminal Coronary Angioplasty, Percutaneous
Applicant Abbott Vascular
26531 YNEZ ROAD
TEMECULA, CA 92591 US
Other 510(k) Applications for this Company
Contact SUZANNE REDMAN
Other 510(k) Applications for this Contact
Regulation Number 000.0000

  More FDA Info for this Regulation Number
Classification Product Code LOX
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 03/03/2011
Decision Date 06/02/2011
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