The following data is part of a premarket notification filed by Hdc Corp. with the FDA for Hdc Vadd (vascular Access Device) Tunneler.
| Device ID | K951098 |
| 510k Number | K951098 |
| Device Name: | HDC VADD (VASCULAR ACCESS DEVICE) TUNNELER |
| Classification | Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
| Applicant | HDC CORP. 2109 O'TOOLE AVE. San Jose, CA 95131 |
| Contact | Gretchen Marchesani |
| Correspondent | Gretchen Marchesani HDC CORP. 2109 O'TOOLE AVE. San Jose, CA 95131 |
| Product Code | LJS |
| CFR Regulation Number | 880.5970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-09 |
| Decision Date | 1995-06-02 |