The following data is part of a premarket notification filed by Professional Medical Services with the FDA for Vertex Percutaneous Catheter Introduc.
| Device ID | K840017 |
| 510k Number | K840017 |
| Device Name: | VERTEX PERCUTANEOUS CATHETER INTRODUC |
| Classification | Dilator, Vessel, For Percutaneous Catheterization |
| Applicant | PROFESSIONAL MEDICAL SERVICES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DRE |
| CFR Regulation Number | 870.1310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-01-04 |
| Decision Date | 1984-02-04 |