The following data is part of a premarket notification filed by Hdc Corp. with the FDA for Modification To V-cath Poly Picc.
| Device ID | K033853 |
| 510k Number | K033853 |
| Device Name: | MODIFICATION TO V-CATH POLY PICC |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | HDC CORP. 628 GIBRALTAR CT. Milpitas, CA 95035 |
| Contact | Earl Smart |
| Correspondent | Earl Smart HDC CORP. 628 GIBRALTAR CT. Milpitas, CA 95035 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-12-11 |
| Decision Date | 2004-01-14 |