The following data is part of a premarket notification filed by Medical Components, Inc. with the FDA for Percutaneous Introducer Set.
| Device ID | K800462 |
| 510k Number | K800462 |
| Device Name: | PERCUTANEOUS INTRODUCER SET |
| Classification | Dilator, Vessel, For Percutaneous Catheterization |
| Applicant | MEDICAL COMPONENTS, INC. 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 | 1980-02-29 |
| Decision Date | 1980-03-19 |