ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLATFORM AND ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS PLATFORM
FDA premarket approval P930038/S036 · decided 2003-05-02
Approval details
- PMA number
- P930038
- Supplement
- S036
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLATFORM AND ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS PLATFORM
- Generic name
- Device, hemostasis, vascular
- Applicant
- Terumo Medical Corporation
- Date received
- 2003-03-31
- Decision date
- 2003-05-02
- Days to decision
- 32 days
- Decision code
- APPR
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Elkton, MD
- Statement
- APPROVAL FOR MODIFYING AND STANDARDIZING THE ABSORBABLE ANCHOR COMPONENT OF THE DEVICE SO THAT THE SAME COMPONENT COULD BE USED IN EITHER MARKETED PLATFORM.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
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 |