AngioVac Circuit
FDA 510(k) clearance K142607 · decided 2014-12-11
Clearance details
- K-number
- K142607
- Device name
- AngioVac Circuit
- Applicant
- Angiodynamics
- Decision
- Substantially Equivalent
- Date received
- 2014-09-15
- Decision date
- 2014-12-11
- Days to decision
- 87 days
- Clearance type
- Traditional
- Product code
- DWE
- Device class
- 2
- Regulation number
- 870.4390
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Marlborough, MA, US
- Third-party review
- No
- Expedited review
- No
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| CHEST DRAINAGE TUBING (K993062) | Olson Medical Sales, Inc. | 1999-12-10 |
| COBE SMARXT TUBING AND CONNECTORS (K981613) | Cobe Cardiovascular, Inc. | 1998-10-26 |
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| AngioVac Circuit Pack (Tandem Packs), REF/Catalog No. 25-187, UPN H965251870, STERILE, Rx recall (Z-1702-2016) | Angiodynamics Inc. (Navilyst Medical Inc.) | 2016-05-20 |