The following data is part of a premarket notification filed by Barrx Medical, Inc. with the FDA for Halo90 Ultra Ablation Catheter.
| Device ID | K120431 |
| 510k Number | K120431 |
| Device Name: | HALO90 ULTRA ABLATION CATHETER |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | BARRX MEDICAL, INC. 540 OAKMEAD PARKWAY Sunnyvale, CA 94085 |
| Contact | Dawn Chang |
| Correspondent | Dawn Chang BARRX MEDICAL, INC. 540 OAKMEAD PARKWAY Sunnyvale, CA 94085 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-02-13 |
| Decision Date | 2012-05-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521189379 | K120431 | 000 |