510(k) K163114
K163114 is an FDA 510(k) premarket notification submitted by Orbusneich Medical, Inc. for the device "Sapphire II PRO". The FDA issued a decision of Substantially Equivalent on Jan 5, 2017. The device falls under product code LOX (Catheters, Transluminal Coronary Angioplasty, Percutaneous), a Class II device regulated under 21 CFR 870.5100. Orbusneich Medical, Inc. has 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 5, 2017
- Date Received
- Nov 7, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheters, Transluminal Coronary Angioplasty, Percutaneous
- Device Class
- Class II
- Regulation Number
- 870.5100
- Review Panel
- CV
- Submission Type
- 510(k)
A PTCA catheter is a device that operates on the principle of hydraulic pressurization applied through an inflatable balloon attached to the distal end.