ANGIO-SEAL VASCULAR DEVICE - 8F AND 6F
FDA premarket approval P930038/S026 · decided 2000-11-29
Approval details
- PMA number
- P930038
- Supplement
- S026
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ANGIO-SEAL VASCULAR DEVICE - 8F AND 6F
- Generic name
- Device, hemostasis, vascular
- Applicant
- Terumo Medical Corporation
- Date received
- 2000-06-27
- Decision date
- 2000-11-29
- Days to decision
- 155 days
- Decision code
- APPR
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Elkton, MD
- Statement
- APPROVAL FOR AN ALTERNATE MANUFACTURING FACILITY LOCATED AT ST. JUDE MEDICAL, PUERTO RICO, CAGUAS, PUERTO RICO.
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 |