VEIN-TRAP TM
FDA 510(k) clearance K811910 · decided 1981-07-20
Clearance details
- K-number
- K811910
- Device name
- VEIN-TRAP TM
- Applicant
- Atrium Medical Corp.
- Decision
- Substantially Equivalent
- Date received
- 1981-07-01
- Decision date
- 1981-07-20
- Days to decision
- 19 days
- Clearance type
- Traditional
- Product code
- DWQ
- Device class
- 2
- Regulation number
- 870.4885
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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| PhasTIPP (K212894) | LeMaitre Vascular, Inc. | 2022-03-31 |
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| URESIL VALVE CUTTER (K905528) | Uresil Corp. | 1991-04-18 |
| PILLING BRUSH VALVULOTOME (K904507) | Pilling Co. | 1991-03-01 |
| INSITUCAT VALVE STRIPPER (K885046) | Aesculap Instruments Corp. | 1990-02-28 |
| HALL VEIN STRIPPER (K872157) | Solco Basle, Inc. | 1987-07-07 |
Recalls involving this device
No recalls on record reference this clearance.
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 |