510(k) K061670

LUNDERQUIST WIRE GUIDE; DC WIRE GUIDE by William Cook Europe Aps — Product Code DQX

K061670 is an FDA 510(k) premarket notification submitted by William Cook Europe Aps for the device "LUNDERQUIST WIRE GUIDE; DC WIRE GUIDE". The FDA issued a decision of Substantially Equivalent on January 19, 2007. The device falls under product code DQX (Wire, Guide, Catheter), a Class II device regulated under 21 CFR 870.1330. William Cook Europe Aps has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 19, 2007
Date Received
June 14, 2006
Clearance Type
Special
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