The following data is part of a premarket notification filed by Stryker Corporation with the FDA for Ivas Balloon Catheter.
| Device ID | K113154 |
| 510k Number | K113154 |
| Device Name: | IVAS BALLOON CATHETER |
| Classification | Cement, Bone, Vertebroplasty |
| Applicant | STRYKER CORPORATION 4100 E. MILHAM AVE. Kalamazoo, MI 49001 |
| Contact | Meghan Arreaza |
| Correspondent | Meghan Arreaza 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 | 2011-10-26 |
| Decision Date | 2012-01-24 |
| Summary: | summary |