The following data is part of a premarket notification filed by Pristine Access Technologies Ltd. with the FDA for Pristine Hemodialysis Catheter.
| Device ID | K182443 |
| 510k Number | K182443 |
| Device Name: | Pristine Hemodialysis Catheter |
| Classification | Catheter, Hemodialysis, Implanted |
| Applicant | Pristine Access Technologies Ltd. 21 (B) Habarzel Street Tel Aviv, IL 6971029 |
| Contact | Ron Livne |
| Correspondent | Orly Maor Orly Maor 25A Sirkin Street Kfar Saba, IL 4442156 |
| Product Code | MSD |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-07 |
| Decision Date | 2019-05-31 |
| Summary: | summary |