510(k) K113628
K113628 is an FDA 510(k) premarket notification submitted by Catheter Robotics, Inc. for the device "AMIGO REMOTE CATHETER SYSTEM (RCS) & ACCESSORIES". The FDA issued a decision of Substantially Equivalent on June 12, 2012. The device falls under product code DXX (System, Catheter Control, Steerable), a Class II device regulated under 21 CFR 870.1290. Catheter Robotics, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 12, 2012
- Date Received
- December 8, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Catheter Control, Steerable
- Device Class
- Class II
- Regulation Number
- 870.1290
- Review Panel
- CV
- Submission Type