510(k) K991097

PBN DRAINAGE CATHETER GUIDEWIRES by Medical Device Technologies, Inc. — Product Code KNY

K991097 is an FDA 510(k) premarket notification submitted by Medical Device Technologies, Inc. for the device "PBN DRAINAGE CATHETER GUIDEWIRES". The FDA issued a decision of Substantially Equivalent on April 23, 1999. The device falls under product code KNY (Accessories, Catheter, G-U), a Class II device regulated under 21 CFR 876.5130. Medical Device Technologies, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 23, 1999
Date Received
April 1, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessories, Catheter, G-U
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
Submission Type