510(k) K031505

RAPIDO CUT-AWAY GUIDING CATHETER by Guidant Corporation — Product Code DQY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 25, 2003
Date Received
May 14, 2003
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Percutaneous
Device Class
Class II
Regulation Number
870.1250
Review Panel
CV
Submission Type