The following data is part of a premarket notification filed by Vascucare, Inc. with the FDA for Vascucare Angiopump.
| Device ID | K881780 |
| 510k Number | K881780 |
| Device Name: | VASCUCARE ANGIOPUMP |
| Classification | Pump, Blood, Cardiopulmonary Bypass, Roller Type |
| Applicant | VASCUCARE, INC. 40 RAMLAND RD. SOUTH Orangeburg, NY 10962 |
| Contact | Wayne E Lipson |
| Correspondent | Wayne E Lipson VASCUCARE, INC. 40 RAMLAND RD. SOUTH Orangeburg, NY 10962 |
| Product Code | DWB |
| CFR Regulation Number | 870.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-04-26 |
| Decision Date | 1988-09-28 |