510(k) K050873

CANALIZER HYDROPHILIC GUIDE WIRE by Medical Device Technologies, Inc. — Product Code DQX

K050873 is an FDA 510(k) premarket notification submitted by Medical Device Technologies, Inc. for the device "CANALIZER HYDROPHILIC GUIDE WIRE". The FDA issued a decision of Substantially Equivalent on May 26, 2005. The device falls under product code DQX (Wire, Guide, Catheter), a Class II device regulated under 21 CFR 870.1330. Medical Device Technologies, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 26, 2005
Date Received
April 6, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wire, Guide, Catheter
Device Class
Class II
Regulation Number
870.1330
Review Panel
CV
Submission Type