The following data is part of a premarket notification filed by Ameco Medical Industries with the FDA for Amecath Dual Lumen Hemodialysis Catheter.
| Device ID | K123943 |
| 510k Number | K123943 |
| Device Name: | AMECATH DUAL LUMEN HEMODIALYSIS CATHETER |
| Classification | Catheter, Hemodialysis, Implanted |
| Applicant | AMECO MEDICAL INDUSTRIES ARAZY GROUP 57 LAZY BROOK RD. Monroe, CT 03468 |
| Contact | Ray Kelly |
| Correspondent | Ray Kelly AMECO MEDICAL INDUSTRIES ARAZY GROUP 57 LAZY BROOK RD. Monroe, CT 03468 |
| Product Code | MSD |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-20 |
| Decision Date | 2013-04-02 |