R2P Destination Slender Guiding Sheath
FDA 510(k) clearance K171491 · decided 2017-10-05
Clearance details
- K-number
- K171491
- Device name
- R2P Destination Slender Guiding Sheath
- Applicant
- Terumo Medical Corporation
- Decision
- Substantially Equivalent
- Date received
- 2017-05-22
- Decision date
- 2017-10-05
- Days to decision
- 136 days
- Clearance type
- Traditional
- Product code
- DYB
- Device class
- 2
- Regulation number
- 870.1340
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Elkton, MD, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| MISAGO® RX Self-expanding Peripheral Stent (P140002/S031) | Terumo Medical Corporation | 2025-12-12 |
| MISAGO® RX Self-expanding Peripheral Stent (P140002/S030) | Terumo Medical Corporation | 2025-09-12 |
| Angio-Seal Vascular Closure Device (P930038/S106) | Terumo Medical Corporation | 2025-08-07 |
| MISAGO® RX Self-expanding Peripheral Stent; R2P Misago RX Self-expanding Peripheral Stent System (P140002/S029) | Terumo Medical Corporation | 2025-08-05 |
| ANGIO-SEAL VIP Vascular Closure Device (P930038/S105) | Terumo Medical Corporation | 2024-11-26 |
| MISAGO RX Self-expanding Peripheral Stent System, R2P MISAGO RX Self-expanding Peripheral Stent System (P140002/S028) | Terumo Medical Corporation | 2024-11-14 |
| Angio-Seal Vascular Closure Device (P930038/S103) | Terumo Medical Corporation | 2024-11-08 |
| Angio-Seal VIP Vascular Closure Devices (P930038/S102) | Terumo Medical Corporation | 2024-08-23 |