The following data is part of a premarket notification filed by Barrx Medical, Incorporated with the FDA for Halo Ablation Catheter, Model 90-9100.
| Device ID | K093008 |
| 510k Number | K093008 |
| Device Name: | HALO ABLATION CATHETER, MODEL 90-9100 |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | BARRX MEDICAL, INCORPORATED 540 OAKMEAD PARKWAY Sunnyvale, CA 94085 |
| Contact | Viorica Filimon |
| Correspondent | Viorica Filimon BARRX MEDICAL, INCORPORATED 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 | 2009-09-28 |
| Decision Date | 2010-01-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521189362 | K093008 | 000 |
| 20884521189390 | K093008 | 000 |
| 10884521581821 | K093008 | 000 |