The following data is part of a premarket notification filed by Xoft, Inc. with the FDA for Axxent Balloon Applicator, Model Ab2034, Ab2045, Ab2056, Ab2057e, Ab2067e.
| Device ID | K090914 |
| 510k Number | K090914 |
| Device Name: | AXXENT BALLOON APPLICATOR, MODEL AB2034, AB2045, AB2056, AB2057E, AB2067E |
| Classification | System, Therapeutic, X-ray |
| Applicant | XOFT, INC. 345 POTRERO AVE. Sunnyvale, CA 94085 |
| Contact | Steve Lin |
| Correspondent | Steve Lin XOFT, INC. 345 POTRERO AVE. Sunnyvale, CA 94085 |
| Product Code | JAD |
| CFR Regulation Number | 892.5900 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-01 |
| Decision Date | 2009-07-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858012005342 | K090914 | 000 |
| 00858012005335 | K090914 | 000 |
| 00858012005328 | K090914 | 000 |
| 00858012005311 | K090914 | 000 |
| 00858012005991 | K090914 | 000 |
| 00858012005984 | K090914 | 000 |
| 00850008977015 | K090914 | 000 |
| 00850008977008 | K090914 | 000 |