510(k) K150201

Quick-Cross Extreme Support Catheter, Quick-Cross Select Support Catheter by Spectranetics, Inc. — Product Code DQY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 27, 2015
Date Received
January 29, 2015
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