510(k) K161596
K161596 is an FDA 510(k) premarket notification submitted by AngioDynamics, Inc. for the device "Soft-Vu, Mariner, Accu-Vu and AngioOptic Catheters". The FDA issued a decision of Substantially Equivalent on Apr 28, 2017. The device falls under product code DQO (Catheter, Intravascular, Diagnostic), a Class II device regulated under 21 CFR 870.1200. AngioDynamics, Inc. has 89 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 28, 2017
- Date Received
- Jun 9, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Intravascular, Diagnostic
- Device Class
- Class II
- Regulation Number
- 870.1200
- Review Panel
- CV
- Submission Type
- 510(k)