510(k) K150322
K150322 is an FDA 510(k) premarket notification submitted by Pan Medical , Ltd. for the device "InterV Kyphoplasty Catheter (Balloon Length: 10,15 and 20mm) InterV Kyphoplasty Catheter (Mini) (Balloon Length: 10, 15 and 20mm)". The FDA issued a decision of Substantially Equivalent on Mar 6, 2015. The device falls under product code NDN (Cement, Bone, Vertebroplasty), a Class II device regulated under 21 CFR 888.3027. Pan Medical , Ltd. has 2 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 6, 2015
- Date Received
- Feb 9, 2015
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Cement, Bone, Vertebroplasty
- Device Class
- Class II
- Regulation Number
- 888.3027
- Review Panel
- OR
- Submission Type
- 510(k)