The following data is part of a premarket notification filed by Ameco Medical Industries with the FDA for Amecath Peripheral Inserted Central Venous Catheter Sets.
| Device ID | K152819 |
| 510k Number | K152819 |
| Device Name: | Amecath Peripheral Inserted Central Venous Catheter Sets |
| Classification | Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
| Applicant | AMECO MEDICAL INDUSTRIES INDUSTRIAL AREA B4-PLOT #119 EAST 10th Of Ramadan City, EG |
| Contact | Samy Hamboly |
| Correspondent | Ray Kelly LICENSALE INC. 57 Lazy Brook Rd. Monroe, CT 06468 |
| Product Code | LJS |
| CFR Regulation Number | 880.5970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-28 |
| Decision Date | 2016-02-05 |