510(k) K142607
K142607 is an FDA 510(k) premarket notification submitted by Angiodynamics for the device "AngioVac Circuit". The FDA issued a decision of Substantially Equivalent on December 11, 2014. The device falls under product code DWE (Tubing, Pump, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4390. Angiodynamics has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 11, 2014
- Date Received
- September 15, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tubing, Pump, Cardiopulmonary Bypass
- Device Class
- Class II
- Regulation Number
- 870.4390
- Review Panel
- CV
- Submission Type