The following data is part of a premarket notification filed by Vascular Technology Incorporated with the FDA for Vti Adult Disposable Skull Pin, Model 22000; Vti Skull Screw, Model 22001.
| Device ID | K002990 |
| 510k Number | K002990 |
| Device Name: | VTI ADULT DISPOSABLE SKULL PIN, MODEL 22000; VTI SKULL SCREW, MODEL 22001 |
| Classification | Holder, Head, Neurosurgical (skull Clamp) |
| Applicant | VASCULAR TECHNOLOGY INCORPORATED 175 CABOT ST. Lowell, MA 01854 |
| Contact | David L Regan |
| Correspondent | David L Regan VASCULAR TECHNOLOGY INCORPORATED 175 CABOT ST. Lowell, MA 01854 |
| Product Code | HBL |
| CFR Regulation Number | 882.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-09-25 |
| Decision Date | 2000-11-06 |