510(k) K212393
K212393 is an FDA 510(k) premarket notification submitted by Sis Medical AG for the device "OPN NC PTCA Dilatation Catheter". The FDA issued a decision of Substantially Equivalent on March 14, 2022. The device falls under product code LOX (Catheters, Transluminal Coronary Angioplasty, Percutaneous), a Class II device regulated under 21 CFR 870.5100.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 14, 2022
- Date Received
- August 2, 2021
- 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.