510(k) K031468
K031468 is an FDA 510(k) premarket notification submitted by Cardinalhealth for the device "TEMPORARY TITANIUM ANEURYSM CLIP". The FDA issued a decision of Substantially Equivalent on June 20, 2003. The device falls under product code HCH (Clip, Aneurysm), a Class II device regulated under 21 CFR 882.5200. Cardinalhealth has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 20, 2003
- Date Received
- May 9, 2003
- 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