THREE STAGE VENOUS RETURN CANNULA, MODEL 816460
FDA 510(k) clearance K080034 · decided 2008-06-17
Clearance details
- K-number
- K080034
- Device name
- THREE STAGE VENOUS RETURN CANNULA, MODEL 816460
- Applicant
- Terumo Cardiovascular Systems Corp.
- Decision
- Substantially Equivalent
- Date received
- 2008-01-07
- Decision date
- 2008-06-17
- Days to decision
- 162 days
- Clearance type
- Traditional
- Product code
- DWF
- Device class
- 2
- Regulation number
- 870.4210
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Ann Arbor, MI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Terumo Three-stage Venous Return Cannulae 28 Fr with 3/8" flare, 30 Fr with 3/8" connector recall (Z-2104-2014) | Terumo Cardiovascular Systems Corporation | 2014-07-23 |