The following data is part of a premarket notification filed by Xanmed Corp. with the FDA for Cardiovascular Custom Surgical Kit.
| Device ID | K844593 |
| 510k Number | K844593 |
| Device Name: | CARDIOVASCULAR CUSTOM SURGICAL KIT |
| Classification | Introducer, Catheter |
| Applicant | XANMED CORP. 815 CONNECTICUT AVENUE NW Washington , DC 20006 - |
| Contact | David B Vance |
| Correspondent | David B Vance XANMED CORP. 815 CONNECTICUT AVENUE NW Washington , DC 20006 - |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-11-26 |
| Decision Date | 1985-06-21 |