510(k) K895903

IVT 0.014 GUIDE WIRE by Intensive Technology, Inc. — Product Code DQX

K895903 is an FDA 510(k) premarket notification submitted by Intensive Technology, Inc. for the device "IVT 0.014 GUIDE WIRE". The FDA issued a decision of Substantially Equivalent on January 4, 1990. The device falls under product code DQX (Wire, Guide, Catheter), a Class II device regulated under 21 CFR 870.1330. Intensive Technology, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 4, 1990
Date Received
October 6, 1989
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