EDRAIN CHEST DRAINAGE SYSTEM
FDA 510(k) clearance K130131 · decided 2013-02-28
Clearance details
- K-number
- K130131
- Device name
- EDRAIN CHEST DRAINAGE SYSTEM
- Applicant
- Atrium Medical Corp.
- Decision
- Substantially Equivalent
- Date received
- 2013-01-18
- Decision date
- 2013-02-28
- Days to decision
- 41 days
- Clearance type
- Traditional
- Product code
- BTA
- Device class
- 2
- Regulation number
- 878.4780
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Hudson, NH, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
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|---|---|---|
| iCast Covered Stent System (P120003/S009) | Atrium Medical Corp. | 2025-12-22 |
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| 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 |