EXPRESS AND OASIS CHEST DRAIN
FDA 510(k) clearance K043140 · decided 2004-12-08
Clearance details
- K-number
- K043140
- Device name
- EXPRESS AND OASIS CHEST DRAIN
- Applicant
- Atrium Medical Corp.
- Decision
- Substantially Equivalent
- Date received
- 2004-11-15
- Decision date
- 2004-12-08
- Days to decision
- 23 days
- Clearance type
- Special
- Product code
- CAC
- Device class
- 2
- Regulation number
- 868.5830
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Hudson, NH, US
- Third-party review
- No
- Expedited review
- No
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| 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 |