The following data is part of a premarket notification filed by Stryker Corporation with the FDA for Ivas 2-10mm (10 Guage) Ballon Catheter.
| Device ID | K103807 |
| 510k Number | K103807 |
| Device Name: | IVAS 2-10MM (10 GUAGE) BALLON CATHETER |
| Classification | Cement, Bone, Vertebroplasty |
| Applicant | STRYKER CORPORATION 4100 E. MILHAM AVE Kalamazoo, MI 49001 |
| Contact | Melissa Kann |
| Correspondent | Melissa Kann STRYKER CORPORATION 4100 E. MILHAM AVE Kalamazoo, MI 49001 |
| Product Code | NDN |
| CFR Regulation Number | 888.3027 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-12-29 |
| Decision Date | 2011-06-28 |
| Summary: | summary |