510(k) K905505

VAS-CATH URETERAL STENTS CATHETER, MODIFICATION by Vas-Cath, Inc. — Product Code FAD

K905505 is an FDA 510(k) premarket notification submitted by Vas-Cath, Inc. for the device "VAS-CATH URETERAL STENTS CATHETER, MODIFICATION". The FDA issued a decision of Substantially Equivalent on April 9, 1991. The device falls under product code FAD (Stent, Ureteral), a Class II device regulated under 21 CFR 876.4620. Vas-Cath, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 9, 1991
Date Received
November 23, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stent, Ureteral
Device Class
Class II
Regulation Number
876.4620
Review Panel
GU
Submission Type