510(k) K964021
K964021 is an FDA 510(k) premarket notification submitted by Baxter Edwards for the device "INTRAMED SIDE BRANCH OCCLUSION (SBO) SYSTEM (700095 AND 700099)". The FDA issued a decision of Substantially Equivalent on March 27, 1997. The device falls under product code HCG (Device, Neurovascular Embolization), a Class II device regulated under 21 CFR 882.5950. Baxter Edwards has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 27, 1997
- Date Received
- October 7, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Neurovascular Embolization
- Device Class
- Class II
- Regulation Number
- 882.5950
- Review Panel
- NE
- Submission Type