The following data is part of a premarket notification filed by Loma Vista Medical with the FDA for True Dilatation Percutaneous Transluminal Valvuloplasty Catheter, 20mm X 4.5cm, True Dilatation Percutaneous Translumina.
| Device ID | K121083 |
| 510k Number | K121083 |
| Device Name: | TRUE DILATATION PERCUTANEOUS TRANSLUMINAL VALVULOPLASTY CATHETER, 20MM X 4.5CM, TRUE DILATATION PERCUTANEOUS TRANSLUMINA |
| Classification | Balloon Aortic Valvuloplasty |
| Applicant | LOMA VISTA MEDICAL 1307 SOUTH MARY AVE, STE 280 Sunnyvale, CA 94087 |
| Contact | Tiffini Diage |
| Correspondent | Tiffini Diage LOMA VISTA MEDICAL 1307 SOUTH MARY AVE, STE 280 Sunnyvale, CA 94087 |
| Product Code | OZT |
| CFR Regulation Number | 870.1255 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-10 |
| Decision Date | 2012-10-11 |
| Summary: | summary |