510(k) K254212
K254212 is an FDA 510(k) premarket notification submitted by Kossel Medtech (Suzhou) Co., Ltd. for the device "NC PTA Balloon Dilatation Catheter". The FDA issued a decision of Substantially Equivalent on September 16, 2026. The device falls under product code LIT (Catheter, Angioplasty, Peripheral, Transluminal), a Class II device regulated under 21 CFR 870.1250. Kossel Medtech (Suzhou) Co., Ltd. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 16, 2026
- Date Received
- December 29, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Angioplasty, Peripheral, Transluminal
- Device Class
- Class II
- Regulation Number
- 870.1250
- Review Panel
- CV
- Submission Type