The following data is part of a premarket notification filed by Embolx, Inc with the FDA for Sniper Infusion Catheter With Balloon Occlusion.
| Device ID | K180904 |
| 510k Number | K180904 |
| Device Name: | Sniper Infusion Catheter With Balloon Occlusion |
| Classification | Catheter, Intravascular Occluding, Temporary |
| Applicant | Embolx, Inc 530 Lakeside, Suite 200 Sunnyvale, CA 94085 |
| Contact | Greg Haistead |
| Correspondent | Dave Yungvirt THIRD PARTY REVIEW GROUP, LLC 25 Independence Blvd Warren, NJ 07059 |
| Product Code | MJN |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2018-04-06 |
| Decision Date | 2018-06-08 |
| Summary: | summary |