The following data is part of a premarket notification filed by Accessclosure, Inc. with the FDA for Paxwire Occlusion Balloon System.
| Device ID | K143613 |
| 510k Number | K143613 |
| Device Name: | PaxWire Occlusion Balloon System |
| Classification | Catheter, Intravascular Occluding, Temporary |
| Applicant | ACCESSCLOSURE, INC. 5452 Besty Ross Drive Santa Clara, CA 95054 |
| Contact | Kelly Jabbal |
| Correspondent | Kelly Jabbal ACCESSCLOSURE, INC. 5452 Besty Ross Drive Santa Clara, CA 95054 |
| Product Code | MJN |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-19 |
| Decision Date | 2015-08-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M465ACX10106 | K143613 | 000 |