The following data is part of a premarket notification filed by Introstat with the FDA for Lead Introducer Set.
| Device ID | K790882 |
| 510k Number | K790882 |
| Device Name: | LEAD INTRODUCER SET |
| Classification | Wire, Guide, Catheter |
| Applicant | INTROSTAT 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-05-08 |
| Decision Date | 1979-06-11 |