The following data is part of a premarket notification filed by Vascular Technologies Ltd. with the FDA for Vein Entry Indicator Device (veid).
| Device ID | K993995 |
| 510k Number | K993995 |
| Device Name: | VEIN ENTRY INDICATOR DEVICE (VEID) |
| Classification | Syringe, Piston |
| Applicant | VASCULAR TECHNOLOGIES LTD. P.O.B. 454 Ginot Shomron, IL 44853 |
| Contact | Ahava Stein |
| Correspondent | Ahava Stein VASCULAR TECHNOLOGIES LTD. P.O.B. 454 Ginot Shomron, IL 44853 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-11-24 |
| Decision Date | 2000-02-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290018896235 | K993995 | 000 |
| 07290018896136 | K993995 | 000 |
| 07290018896037 | K993995 | 000 |