DRC
- Product code
- DRC
- Device name
- Trocar
- Device class
- Class 2
- 21 CFR
- 21 CFR 870.1390
- Medical specialty
- Cardiovascular
- Marketing pathway
- 510(K) Exempt
- 510(k) clearances (last 3 years)
- 51
510(k) clearances, last 3 years (2)
| Number | Decision date | Applicant | Device name |
|---|---|---|---|
| K240246 | 2024-07-26 | Synaptic Medical Corporation | Accusafe Transseptal Guidewire (GTR31180, GTR31230) summary |
| K241042 | 2024-05-17 | Pressure Products Medical Device Manuf | SafeSharp Transseptal Needle (CLICK071, CLICK171, CL summary |
Official FDA classification page: DRC
Classification and pathway per current FDA publications. Data from openFDA (CC0).