The following data is part of a premarket notification filed by Stryker Instruments, Instruments Div. with the FDA for Ivas 2-10mm (10 Gauge) Balloon Catheter, Ivas 2-15 Mm(10 Gauge)0705-115-500, Ivas 3-10mm(8 Gauge)balloon Catheter, Ivas.
| Device ID | K093419 |
| 510k Number | K093419 |
| Device Name: | IVAS 2-10MM (10 GAUGE) BALLOON CATHETER, IVAS 2-15 MM(10 GAUGE)0705-115-500, IVAS 3-10MM(8 GAUGE)BALLOON CATHETER, IVAS |
| Classification | Cement, Bone, Vertebroplasty |
| Applicant | STRYKER INSTRUMENTS, INSTRUMENTS DIV. 4100 EAST MILHAM AVE. Kalamazoo, MI 49001 |
| Contact | Becky E Ditty |
| Correspondent | Becky E Ditty 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 | 2009-11-02 |
| Decision Date | 2010-03-18 |
| Summary: | summary |