The following data is part of a premarket notification filed by Hdc Corp. with the FDA for V-cath.
| Device ID | K964966 |
| 510k Number | K964966 |
| Device Name: | V-CATH |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less 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 | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-12-11 |
| Decision Date | 1997-03-05 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() V-CATH 76187003 2506689 Dead/Cancelled |
NEO MEDICAL INC. 2000-12-27 |
![]() V-CATH 74014806 1656725 Dead/Cancelled |
HDC CORPORATION 1989-12-28 |