The following data is part of a premarket notification filed by Medicalcv, Inc. with the FDA for Northrup Universal Annuloplasty System, Model 1000.
| Device ID | K033685 |
| 510k Number | K033685 |
| Device Name: | NORTHRUP UNIVERSAL ANNULOPLASTY SYSTEM, MODEL 1000 |
| Classification | Ring, Annuloplasty |
| Applicant | MEDICALCV, INC. 9725 SOUTH ROBERT TRAIL Inver Grove Heights, MN 55077 |
| Contact | Denny Steger |
| Correspondent | Denny Steger MEDICALCV, INC. 9725 SOUTH ROBERT TRAIL Inver Grove Heights, MN 55077 |
| Product Code | KRH |
| CFR Regulation Number | 870.3800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-11-24 |
| Decision Date | 2004-08-03 |
| Summary: | summary |