The following data is part of a premarket notification filed by Mederi Therapeutics Inc. with the FDA for Stretta Catheter.
| Device ID | K152317 |
| 510k Number | K152317 |
| Device Name: | Stretta Catheter |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | MEDERI THERAPEUTICS INC. 800 Connecticut Ave, 1E01 Norwalk, CT 06854 |
| Contact | Oleg Shikhman |
| Correspondent | Michele Lucey Lakeshore Medical Device Consulting, LLC 128 Blye Hill Landing Newbury, NH 03255 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-17 |
| Decision Date | 2015-09-23 |
| Summary: | summary |