510(k) K211393
K211393 is an FDA 510(k) premarket notification submitted by Kossel Medtech (Suzhou) Co., Ltd. for the device "Selethru(TM) NC PTCA Balloon Dilatation Catheter". The FDA issued a decision of Substantially Equivalent on July 2, 2021. The device falls under product code LOX (Catheters, Transluminal Coronary Angioplasty, Percutaneous), a Class II device regulated under 21 CFR 870.5100. Kossel Medtech (Suzhou) Co., Ltd. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 2, 2021
- Date Received
- May 5, 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.