NC PTA Balloon Dilatation Catheter— 510(k) K254212
Substantially EquivalentKossel Medtech (Suzhou) Co., Ltd.
FDA 510(k) clearance K254212 for NC PTA Balloon Dilatation Catheter, Substantially Equivalent on 2026-09-16. Applicant: Kossel Medtech (Suzhou) Co., Ltd.. Device class: 2.
Summary
NC PTA Balloon Dilatation Catheter comes from Kossel Medtech (Suzhou) Co., Ltd. under product code LIT (Catheter, Angioplasty, Peripheral, Transluminal). The record gives no sizes or models.
Class II, 21 CFR 870.1250. Cardiovascular is both the classification panel and the review panel, and it came in as a Traditional 510(k). The decision was Substantially Equivalent.
Kossel filed from Suzhou New District, China. The decision came 261 calendar days after FDA received it (December 29, 2025 to September 16, 2026).
Clearance details
- Applicant
- Kossel Medtech (Suzhou) Co., Ltd.
- Product code
- Product code LIT
- Device class
- Class 2
- Regulation
- 21 CFR 870.1250
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Suzhou New District, CN
Recent devices under product code LIT
view allMore clearances from Kossel Medtech (Suzhou) Co., Ltd.
view allAdverse events under product code LIT
product code LIT- Death
- 27
- Injury
- 1,256
- Malfunction
- 12,127
- Total
- 13,410
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.