The following data is part of a premarket notification filed by Stryker Instruments, Instruments Div. with the FDA for Ivas 20mm (10 Gauge) Balloon Catheter.
| Device ID | K113477 |
| 510k Number | K113477 |
| Device Name: | IVAS 20MM (10 GAUGE) BALLOON CATHETER |
| Classification | Cement, Bone, Vertebroplasty |
| Applicant | STRYKER INSTRUMENTS, INSTRUMENTS DIV. 4100 EAST MILHAM AVE. Kalamazoo, MI 49001 |
| Contact | Christina Mckee |
| Correspondent | Christina Mckee STRYKER INSTRUMENTS, INSTRUMENTS DIV. 4100 EAST 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 | 2011-11-23 |
| Decision Date | 2012-01-06 |
| Summary: | summary |