510(k) K931586

VITAL-PORT MINI VASCULAR ACCESS SYSTEM by Med Institute, Inc. — Product Code DWF

K931586 is an FDA 510(k) premarket notification submitted by Med Institute, Inc. for the device "VITAL-PORT MINI VASCULAR ACCESS SYSTEM". The FDA issued a decision of Substantially Equivalent (kit) on September 27, 1993. The device falls under product code DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4210. Med Institute, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
September 27, 1993
Date Received
March 31, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4210
Review Panel
CV
Submission Type