DTI
7 FDA 510(k) clearances · Product code
86 daysmedian time to decision
204 days90th percentile
7clearances measured
FDA profile
- Official device name
- Sizer, Heart-Valve, Prosthesis
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 870.3945
- Medical specialty
- Cardiovascular
- Adverse events (MAUDE)
- 2007: 6 · 2008: 84 · 2009: 23 · 2010: 4 · 2014: 6 · 2023: 27
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| CARBOMEDICS SUPRA-ANNULAR VALVE SIZER (K952184) | Carbomedics, Inc. | 1995-11-29 |
| VALVE SIZER (K934951) | Carbomedics, Inc. | 1993-12-10 |
| EDWARDS-DUROMEDICS BILEAFLET VALVE SIZER SET (K881279) | Baxter Healthcare Corp | 1988-05-18 |
| DUROMEDICS CARDIAC VALVE SIZER SET (K853313) | Hemex Scientific, Inc. | 1985-11-01 |
| METRONIC MODEL F7700 HEART VALVE SIZERS (K852612) | Medtronic Vascular | 1985-09-23 |
| MITRAL VALVE ORIFICE SIZER (K820887) | Celtech | 1982-07-08 |
| HANCOCK * OBTURATORS (K801885) | Hancock Laboratories, Inc. | 1980-09-09 |
Track DTI automatically
Every clearance here is in the API, with alerts when new ones post.