FDA 510(k) Application Details - K971577

Device Classification Name Catheter, Angioplasty, Peripheral, Transluminal

  More FDA Info for this Device
510(K) Number K971577
Device Name Catheter, Angioplasty, Peripheral, Transluminal
Applicant CARDIOVASCULAR DYNAMICS, INC.
13700 ALTON PKWY.
IRVINE, CA 92618 US
Other 510(k) Applications for this Company
Contact PAM MISAJON
Other 510(k) Applications for this Contact
Regulation Number 870.1250

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

  More FDA Info for this Product Code
Date Received 04/21/1997
Decision Date 06/18/1997
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