The following data is part of a premarket notification filed by Embolx, Inc. with the FDA for Occlusion Balloon Catheter.
| Device ID | K142692 |
| 510k Number | K142692 |
| Device Name: | Occlusion Balloon Catheter |
| Classification | Catheter, Intravascular Occluding, Temporary |
| Applicant | EMBOLX, INC. 5760 Arboretum Drive Los Altos, CA 94024 |
| Contact | Michael P Allen |
| Correspondent | Craig J Coombs COOMBS MEDICAL DEVICE CONSULTING 1193 SHERMAN STREET Alameda, CA 94501 |
| Product Code | MJN |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-22 |
| Decision Date | 2015-05-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B323SA00900 | K142692 | 000 |