The following data is part of a premarket notification filed by Pan Medical Ltd. with the FDA for 13g Interv Kyphoplasty Catheter (micro) And 11g Interv Kyphoplasty Catheter (mini-flex).
| Device ID | K162453 |
| 510k Number | K162453 |
| Device Name: | 13G InterV Kyphoplasty Catheter (Micro) And 11G InterV Kyphoplasty Catheter (Mini-Flex) |
| 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, Barnwood Gloucester, 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 | 2016-09-01 |
| Decision Date | 2016-11-01 |
| Summary: | summary |