510(k) K023303

EXPORT ASPIRATION CATHETER by Medtronic Vascular — Product Code NFA

K023303 is an FDA 510(k) premarket notification submitted by Medtronic Vascular for the device "EXPORT ASPIRATION CATHETER". The FDA issued a decision of Substantially Equivalent on October 29, 2002. The device falls under product code NFA (Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection), a Class II device regulated under 21 CFR 870.1250. Medtronic Vascular has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 29, 2002
Date Received
October 3, 2002
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection
Device Class
Class II
Regulation Number
870.1250
Review Panel
CV
Submission Type