The following data is part of a premarket notification filed by Vascular Technology Incorporated with the FDA for Vti Intraoperative Doppler Systems.
| Device ID | K082870 |
| 510k Number | K082870 |
| Device Name: | VTI INTRAOPERATIVE DOPPLER SYSTEMS |
| Classification | Flowmeter, Blood, Cardiovascular |
| Applicant | VASCULAR TECHNOLOGY INCORPORATED 12 MURPHY DR. Nashua, NH 03062 |
| Contact | David L Regan |
| Correspondent | David L Regan VASCULAR TECHNOLOGY INCORPORATED 12 MURPHY DR. Nashua, NH 03062 |
| Product Code | DPW |
| CFR Regulation Number | 870.2100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-29 |
| Decision Date | 2008-10-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817122020560 | K082870 | 000 |
| 10817122020239 | K082870 | 000 |
| 10817122020246 | K082870 | 000 |
| 10817122020253 | K082870 | 000 |
| 10817122020260 | K082870 | 000 |
| 10817122020277 | K082870 | 000 |
| 10817122020284 | K082870 | 000 |
| 10817122020291 | K082870 | 000 |
| 10817122020307 | K082870 | 000 |
| 10817122020222 | K082870 | 000 |
| 10817122020215 | K082870 | 000 |
| 10817122020208 | K082870 | 000 |
| 00817122020577 | K082870 | 000 |
| 00817122020584 | K082870 | 000 |
| 10817122020048 | K082870 | 000 |
| 10817122020154 | K082870 | 000 |
| 10817122020161 | K082870 | 000 |
| 10817122020178 | K082870 | 000 |
| 10817122020185 | K082870 | 000 |
| 10817122020192 | K082870 | 000 |
| 10817122020314 | K082870 | 000 |
| 10817122020338 | K082870 | 000 |
| 00817122020324 | K082870 | 000 |
| 00817122020348 | K082870 | 000 |
| 00817122020355 | K082870 | 000 |
| 00817122020362 | K082870 | 000 |
| 00817122020379 | K082870 | 000 |
| 00817122020386 | K082870 | 000 |
| 00817122020393 | K082870 | 000 |
| 00817122020409 | K082870 | 000 |
| 00817122020140 | K082870 | 000 |
| 00817122020133 | K082870 | 000 |
| 00817122020126 | K082870 | 000 |
| 10817122020444 | K082870 | 000 |
| 10817122020468 | K082870 | 000 |
| 00817122020508 | K082870 | 000 |
| 00817122020058 | K082870 | 000 |
| 00817122020089 | K082870 | 000 |
| 00817122020096 | K082870 | 000 |
| 00817122020102 | K082870 | 000 |
| 00817122020119 | K082870 | 000 |
| 00817122020454 | K082870 | 000 |