The following data is part of a premarket notification filed by Dfine, Inc. with the FDA for Ablation Instrument, Model 1635; Ablation Multiplex Catheter, Model 1682.
| Device ID | K091310 |
| 510k Number | K091310 |
| Device Name: | ABLATION INSTRUMENT, MODEL 1635; ABLATION MULTIPLEX CATHETER, MODEL 1682 |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | DFINE, INC. 3047 ORCHARD PKWY. San Jose, CA 95134 |
| Contact | Sandeep Saboo |
| Correspondent | Sandeep Saboo DFINE, INC. 3047 ORCHARD PKWY. San Jose, CA 95134 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-05-04 |
| Decision Date | 2010-08-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884450379899 | K091310 | 000 |
| 00850696006684 | K091310 | 000 |
| 00850696006677 | K091310 | 000 |
| 00850696006660 | K091310 | 000 |
| 00850696006653 | K091310 | 000 |
| 00850696006646 | K091310 | 000 |
| 00850696006271 | K091310 | 000 |
| 00850696006264 | K091310 | 000 |
| 00850696006257 | K091310 | 000 |
| 00850696006240 | K091310 | 000 |
| 00850696006011 | K091310 | 000 |
| 00850696006004 | K091310 | 000 |
| 10884450296032 | K091310 | 000 |
| 00884450488553 | K091310 | 000 |
| 10884450488321 | K091310 | 000 |
| 00850696006691 | K091310 | 000 |
| 10884450296001 | K091310 | 000 |
| 00884450379882 | K091310 | 000 |
| 00884450379875 | K091310 | 000 |
| 00884450374382 | K091310 | 000 |
| 00884450374283 | K091310 | 000 |
| 00884450320686 | K091310 | 000 |
| 00884450320679 | K091310 | 000 |
| 00884450320662 | K091310 | 000 |
| 00884450320655 | K091310 | 000 |
| 00884450320648 | K091310 | 000 |
| 10884450296117 | K091310 | 000 |
| 10884450296100 | K091310 | 000 |
| 10884450296094 | K091310 | 000 |
| 10884450296087 | K091310 | 000 |
| 00884450296011 | K091310 | 000 |
| 00884450488560 | K091310 | 000 |