The following data is part of a premarket notification filed by Marwood Medical, Inc. with the FDA for Cardiovascular Set Up.
| Device ID | K850341 |
| 510k Number | K850341 |
| Device Name: | CARDIOVASCULAR SET UP |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | MARWOOD MEDICAL, INC. BOX 8712 Greensboro, NC 27410 |
| Contact | Denise Ranck |
| Correspondent | Denise Ranck MARWOOD MEDICAL, INC. BOX 8712 Greensboro, NC 27410 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-01-28 |
| Decision Date | 1985-02-25 |