MISAGO RX Self-expanding Peripheral Stent System, R2P MISAGO RX Self-expanding Peripheral Stent System
FDA premarket approval P140002/S028 · decided 2024-11-14
Approval details
- PMA number
- P140002
- Supplement
- S028
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MISAGO RX Self-expanding Peripheral Stent System, R2P MISAGO RX Self-expanding Peripheral Stent System
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Applicant
- Terumo Medical Corporation
- Date received
- 2024-10-11
- Decision date
- 2024-11-14
- Days to decision
- 34 days
- Decision code
- OK30
- Product code
- NIP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Hatagaya
- Statement
- to modify the sterilization cycle and reduce incubation time for a external process challenge device.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| R2P Navicross (K231044) | Terumo Medical Corporation | 2023-07-27 |
| TR BAND Radial Compression Device (K213531) | Terumo Medical Corporation | 2021-12-20 |
| R2P Destination Slender Guiding Sheath (K193125) | Terumo Medical Corporation | 2020-01-06 |
| Glidesheath Slender Tibial Pedal Kit (K181237) | Terumo Medical Corporation | 2018-08-03 |
| Glidesheath Slender (K173831) | Terumo Medical Corporation | 2018-05-08 |
| Destination Carotid Guiding Sheath, Destination Peripheral Guiding Sheath, Destination Renal Guiding Sheath (K172995) | Terumo Medical Corporation | 2017-11-21 |
| R2P Destination Slender Guiding Sheath (K171491) | Terumo Medical Corporation | 2017-10-05 |
| Glidesheath (K152173) | Terumo Medical Corporation | 2015-12-01 |