510(k) K913556
K913556 is an FDA 510(k) premarket notification submitted by Ivalon for the device "IVALON EMBOLIZATION PARTICLES". The FDA issued a decision of Substantially Equivalent on April 13, 1994. The device falls under product code HCG (Device, Neurovascular Embolization), a Class II device regulated under 21 CFR 882.5950. Ivalon has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 13, 1994
- Date Received
- August 9, 1991
- 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