The following data is part of a premarket notification filed by Hdc Corp. with the FDA for Hdc Silcath Subclavian Catheter Percutaneous Inser.
| Device ID | K851078 |
| 510k Number | K851078 |
| Device Name: | HDC SILCATH SUBCLAVIAN CATHETER PERCUTANEOUS INSER |
| Classification | Introducer, Catheter |
| Applicant | HDC CORP. 2551 CASEY AVE. Mountain View, CA 94043 |
| Contact | Stephen K Parks |
| Correspondent | Stephen K Parks HDC CORP. 2551 CASEY AVE. Mountain View, CA 94043 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-03-18 |
| Decision Date | 1985-04-19 |