ATRIUM ICAST COVERED STENT
FDA 510(k) clearance K050814 · decided 2005-05-06
Clearance details
- K-number
- K050814
- Device name
- ATRIUM ICAST COVERED STENT
- Applicant
- Atrium Medical Corp.
- Decision
- Substantially Equivalent
- Date received
- 2005-03-31
- Decision date
- 2005-05-06
- Days to decision
- 36 days
- Clearance type
- Special
- Product code
- JCT
- Device class
- 2
- Regulation number
- 878.3720
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Hudson, NH, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Atrium Medical Corp.
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
| Record | Firm | Date |
|---|---|---|
| iCast Covered Stent System Product Code/Part Number: 85400 85401 85402 85403 85404 85405 8 recall (Z-1077-2022) | Atrium Medical Corporation | 2022-05-18 |
| Atrium iCAST Balloon Expandable Covered Stent; 7mm x 22mm x 120cm; Model/Part Number 85455 recall (Z-2761-2017) | Atrium Medical Corporation | 2017-07-07 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| iCast Covered Stent System (P120003/S009) | Atrium Medical Corp. | 2025-12-22 |
| iCast Covered Stent System (P120003/S011) | Atrium Medical Corp. | 2025-09-12 |
| iCast Covered Stent System (P120003/S010) | Atrium Medical Corp. | 2025-08-20 |
| iCast Covered Stent System (P120003/S006) | Atrium Medical Corp. | 2025-07-07 |
| iCast Covered Stent System (P120003/S008) | Atrium Medical Corp. | 2025-05-01 |
| iCast Covered Stent System (P120003/S005) | Atrium Medical Corp. | 2024-08-07 |
| iCast Covered Stent System (P120003/S004) | Atrium Medical Corp. | 2024-07-24 |
| iCast Covered Stent System (P120003/S003) | Atrium Medical Corp. | 2023-10-18 |