The following data is part of a premarket notification filed by Huntleigh Healthcare, Inc. with the FDA for Vascular Assist.
| Device ID | K002186 |
| 510k Number | K002186 |
| Device Name: | VASCULAR ASSIST |
| Classification | Flowmeter, Blood, Cardiovascular |
| Applicant | HUNTLEIGH HEALTHCARE, INC. 40 CHRISTOPHER WAY Eatontown, NJ 07724 -3327 |
| Contact | Audrey A Witko |
| Correspondent | Audrey A Witko HUNTLEIGH HEALTHCARE, INC. 40 CHRISTOPHER WAY Eatontown, NJ 07724 -3327 |
| Product Code | DPW |
| Subsequent Product Code | JAF |
| Subsequent Product Code | JOM |
| CFR Regulation Number | 870.2100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-07-20 |
| Decision Date | 2001-05-02 |