The following data is part of a premarket notification filed by Upstream Peripheral Technologies, Ltd. with the FDA for Upstream Goback Crossing Catheter.
| Device ID | K182937 |
| 510k Number | K182937 |
| Device Name: | Upstream GoBack Crossing Catheter |
| Classification | Catheter, Percutaneous |
| Applicant | Upstream Peripheral Technologies, Ltd. ARAN Building, P.O. Box 3067; 43 Ha'Eshel Street Caesarea, IL 3088900 |
| Contact | Dan Rottenberg |
| Correspondent | Janice M. Hogan Hogan Lovells US LLP 1735 Market Street, 23rd Floor Philadelphia, PA 19103 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-10-22 |
| Decision Date | 2019-05-23 |