TERUMO ASPRIATION CATHETER
FDA 510(k) clearance K112382 · decided 2011-12-14
Clearance details
- K-number
- K112382
- Device name
- TERUMO ASPRIATION CATHETER
- Applicant
- Terumo Medical Corporation
- Decision
- Substantially Equivalent
- Date received
- 2011-08-18
- Decision date
- 2011-12-14
- Days to decision
- 118 days
- Clearance type
- Traditional
- Product code
- QEZ
- Device class
- 2
- Regulation number
- 870.5150
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Elkton, MD, US
- Third-party review
- Yes
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Terumo Medical Corporation
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| MISAGO® RX Self-expanding Peripheral Stent (P140002/S031) | Terumo Medical Corporation | 2025-12-12 |
| MISAGO® RX Self-expanding Peripheral Stent (P140002/S030) | Terumo Medical Corporation | 2025-09-12 |
| Angio-Seal Vascular Closure Device (P930038/S106) | Terumo Medical Corporation | 2025-08-07 |
| MISAGO® RX Self-expanding Peripheral Stent; R2P Misago RX Self-expanding Peripheral Stent System (P140002/S029) | Terumo Medical Corporation | 2025-08-05 |
| ANGIO-SEAL VIP Vascular Closure Device (P930038/S105) | Terumo Medical Corporation | 2024-11-26 |
| MISAGO RX Self-expanding Peripheral Stent System, R2P MISAGO RX Self-expanding Peripheral Stent System (P140002/S028) | Terumo Medical Corporation | 2024-11-14 |
| Angio-Seal Vascular Closure Device (P930038/S103) | Terumo Medical Corporation | 2024-11-08 |
| Angio-Seal VIP Vascular Closure Devices (P930038/S102) | Terumo Medical Corporation | 2024-08-23 |