510(k) K051179
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