510(k) K030392
K030392 is an FDA 510(k) premarket notification submitted by Micro Therapeutics, Inc. for the device "SAPPHIRE DETACHABLE COIL SYSTEM". The FDA issued a decision of Substantially Equivalent on July 21, 2003. The device falls under product code HCG (Device, Neurovascular Embolization), a Class II device regulated under 21 CFR 882.5950. Micro Therapeutics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 21, 2003
- Date Received
- February 5, 2003
- 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