510(k) K990202
K990202 is an FDA 510(k) premarket notification submitted by Mizuho America, Inc. for the device "SUGITA TITANIUM ANEURYSM CLIP". The FDA issued a decision of Substantially Equivalent on June 4, 1999. The device falls under product code HCH (Clip, Aneurysm), a Class II device regulated under 21 CFR 882.5200. Mizuho America, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 4, 1999
- Date Received
- January 21, 1999
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Clip, Aneurysm
- Device Class
- Class II
- Regulation Number
- 882.5200
- Review Panel
- NE
- Submission Type