Cross-Seal Suture-Mediated Vascular Closure Device System
FDA premarket approval P210017 · decided 2023-09-26
Approval details
- PMA number
- P210017
- Trade name
- Cross-Seal Suture-Mediated Vascular Closure Device System
- Generic name
- Device, hemostasis, vascular
- Applicant
- Terumo Medical Corporation
- Date received
- 2021-04-29
- Decision date
- 2023-09-26
- Days to decision
- 880 days
- Decision code
- APPR
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Somerset, NJ
- Statement
- Approval for the Cross-Seal Suture-Mediated Vascular Closure Device System. The device is indicated for the percutaneous delivery of sutures for closing the common femoral artery access site while reducing time-to-hemostasis in patients who have undergone diagnostic or interventional catheterization procedures using 8F to 18F sheaths. The Cross-Seal System is indicated for one access site per leg.
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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 |