510(k) K022242

INTERVASCULAR INTERGARD KNITTED VASCULAR GRAFT SIZER by Intervascular — Product Code DSY

K022242 is an FDA 510(k) premarket notification submitted by Intervascular for the device "INTERVASCULAR INTERGARD KNITTED VASCULAR GRAFT SIZER". The FDA issued a decision of Substantially Equivalent on Aug 14, 2002. The device falls under product code DSY (Prosthesis, Vascular Graft, Of 6mm And Greater Diameter), a Class II device regulated under 21 CFR 870.3450. Intervascular has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Aug 14, 2002
Date Received
Jul 11, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Device Class
Class II
Regulation Number
870.3450
Review Panel
CV
Submission Type