T-ANASTAFLO
FDA 510(k) clearance K990396 · decided 1999-10-01
Clearance details
- K-number
- K990396
- Device name
- T-ANASTAFLO
- Applicant
- Edwards Lifesciences Research Medical
- Decision
- Substantially Equivalent
- Date received
- 1999-02-09
- Decision date
- 1999-10-01
- Days to decision
- 234 days
- Clearance type
- Traditional
- Product code
- DWF
- Device class
- 2
- Regulation number
- 870.4210
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Midvale, UT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Edwards Lifesciences Anastaflo Intravascular Shunt, Model code IVS12512, IVS1512, IVS17512 recall (Z-1963-2013) | Edwards Lifesciences, LLC | 2013-08-14 |