510(k) K051179

EZ PLUS RETRIEVAL SHEATH, MODEL 38899-150 by Boston Scientific Corp — Product Code NFA

K051179 is an FDA 510(k) premarket notification submitted by Boston Scientific Corp for the device "EZ PLUS RETRIEVAL SHEATH, MODEL 38899-150". The FDA issued a decision of Substantially Equivalent on June 8, 2005. 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. Boston Scientific Corp has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 8, 2005
Date Received
May 9, 2005
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