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)
- 2
- Summaries archived here
- 1 (direct download)
- 510(k) clearances (all years, FDA)
- 51 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (2)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K240246 | 2024-07-26 | Synaptic Medical Corporation | Accusafe Transseptal Guidewire (GTR31180, GTR31230) | FDA |
| K241042 | 2024-05-17 | Pressure Products Medical Device Manuf… | SafeSharp Transseptal Needle (CLICK071, CLICK171, CL… |
Official FDA classification page: DRC
Classification and pathway per current FDA publications. Data from openFDA (CC0).