The following data is part of a premarket notification filed by Hdc Corp. with the FDA for V-cath Picc (peripherally Inserted Central Catheter) See Appendix 1.
| Device ID | K983409 |
| 510k Number | K983409 |
| Device Name: | V-CATH PICC (PERIPHERALLY INSERTED CENTRAL CATHETER) SEE APPENDIX 1 |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | HDC CORP. 2109 O'TOOLE AVE. San Jose, CA 95131 |
| Contact | James S Abilla |
| Correspondent | James S Abilla HDC CORP. 2109 O'TOOLE AVE. San Jose, CA 95131 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-28 |
| Decision Date | 1998-10-16 |