The following data is part of a premarket notification filed by Ameco Medical Industries with the FDA for Ameco Sheath Introducer.
| Device ID | K131144 |
| 510k Number | K131144 |
| Device Name: | AMECO SHEATH INTRODUCER |
| Classification | Introducer, Catheter |
| Applicant | AMECO MEDICAL INDUSTRIES 57 LAZY BROOK RD Monroe, CT 06468 |
| Contact | Raymond J Kelly |
| Correspondent | Raymond J Kelly AMECO MEDICAL INDUSTRIES 57 LAZY BROOK RD Monroe, CT 06468 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-04-23 |
| Decision Date | 2013-08-15 |