The following data is part of a premarket notification filed by Stryker Corporation with the FDA for Ivas 10mm And 15mm Balloon Catheter.
| Device ID | K130430 |
| 510k Number | K130430 |
| Device Name: | IVAS 10MM AND 15MM BALLOON CATHETER |
| Classification | Arthroscope |
| 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 | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-02-20 |
| Decision Date | 2013-05-23 |
| Summary: | summary |