The following data is part of a premarket notification filed by Marwood Medical, Inc. with the FDA for Cardiac Catheterization Pack.
| Device ID | K850337 |
| 510k Number | K850337 |
| Device Name: | CARDIAC CATHETERIZATION PACK |
| Classification | Dilator, Vessel, For Percutaneous Catheterization |
| 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 | DRE |
| CFR Regulation Number | 870.1310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-01-28 |
| Decision Date | 1985-02-25 |