The following data is part of a premarket notification filed by Xanmed Corp. with the FDA for Subclavian Lead Introducer Sys.
| Device ID | K843642 |
| 510k Number | K843642 |
| Device Name: | SUBCLAVIAN LEAD INTRODUCER SYS |
| Classification | Introducer, Catheter |
| Applicant | XANMED CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-09-17 |
| Decision Date | 1984-10-23 |