ANGIO-SEAL HEMOSTATIC PUNCTURE CLOSURE DEVICE
FDA premarket approval P930038/S018 · decided 1999-04-27
Approval details
- PMA number
- P930038
- Supplement
- S018
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ANGIO-SEAL HEMOSTATIC PUNCTURE CLOSURE DEVICE
- Generic name
- Device, hemostasis, vascular
- Applicant
- Terumo Medical Corporation
- Date received
- 1999-04-05
- Decision date
- 1999-04-27
- Days to decision
- 22 days
- Decision code
- APPR
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Elkton, MD
- Statement
- Approval for a modification to the collagen sponge shape.
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 |