The following data is part of a premarket notification filed by Professional Medical Services with the FDA for Vertex Digital Substration Kit.
| Device ID | K830637 |
| 510k Number | K830637 |
| Device Name: | VERTEX DIGITAL SUBSTRATION KIT |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | PROFESSIONAL MEDICAL SERVICES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-03-01 |
| Decision Date | 1983-03-24 |