510(k) K180921
K180921 is an FDA 510(k) premarket notification submitted by Orbusneich Medical Trading, Inc. for the device "Sapphire II PRO Balloon Dilatation Catheter". The FDA issued a decision of Substantially Equivalent on June 28, 2018. The device falls under product code LOX (Catheters, Transluminal Coronary Angioplasty, Percutaneous), a Class II device regulated under 21 CFR 870.5100. Orbusneich Medical Trading, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 28, 2018
- Date Received
- April 9, 2018
- 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
A PTCA catheter is a device that operates on the principle of hydraulic pressurization applied through an inflatable balloon attached to the distal end.