The following data is part of a premarket notification filed by Hdc Corp. with the FDA for V-cath Percutaneous Introducer Kit.
| Device ID | K951384 |
| 510k Number | K951384 |
| Device Name: | V-CATH PERCUTANEOUS INTRODUCER KIT |
| Classification | Introducer, Syringe Needle |
| 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 | KZH |
| CFR Regulation Number | 880.6920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-27 |
| Decision Date | 1995-06-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B339914125 | K951384 | 000 |
| B3393000085 | K951384 | 000 |
| B33930290035 | K951384 | 000 |
| B33930530035 | K951384 | 000 |
| B33930580045 | K951384 | 000 |
| B3394000085 | K951384 | 000 |
| B33940530035 | K951384 | 000 |
| B3395000085 | K951384 | 000 |
| B33950290035 | K951384 | 000 |
| B33950530035 | K951384 | 000 |
| B339914085 | K951384 | 000 |
| B339914105 | K951384 | 000 |
| B339914115 | K951384 | 000 |
| B33919580045 | K951384 | 000 |