The following data is part of a premarket notification filed by Stryker Corporation with the FDA for Stryker Ivas Balloon Catheter.
| Device ID | K123942 |
| 510k Number | K123942 |
| Device Name: | STRYKER IVAS BALLOON CATHETER |
| Classification | Cement, Bone, Vertebroplasty |
| Applicant | STRYKER CORPORATION 4100 E. MILHAM AVE Kalamazoo, MI 49001 |
| Contact | Christina Mckee |
| Correspondent | Christina Mckee 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 | 2012-12-20 |
| Decision Date | 2013-04-03 |
| Summary: | summary |