The following data is part of a premarket notification filed by Pan Medical Ltd with the FDA for Interv Kyphoplasty Catheter (balloon Length: 10,15 And 20mm) Interv Kyphoplasty Catheter (mini) (balloon Length: 10, 15 And 20mm).
| Device ID | K150322 |
| 510k Number | K150322 |
| Device Name: | InterV Kyphoplasty Catheter (Balloon Length: 10,15 And 20mm) InterV Kyphoplasty Catheter (Mini) (Balloon Length: 10, 15 And 20mm) |
| Classification | Cement, Bone, Vertebroplasty |
| Applicant | PAN MEDICAL LTD BARNETT WAY, BARNWOOD Gloucester, GB Gl4 3rt |
| Contact | Jennie Budding |
| Correspondent | Jennie Budding PAN MEDICAL LTD BARNETT WAY Gloucester, Gloucestershire, GB Gl4 3rt |
| Product Code | NDN |
| CFR Regulation Number | 888.3027 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-02-09 |
| Decision Date | 2015-03-06 |
| Summary: | summary |