# Kossel Medtech (Suzhou) Co., Ltd.

- Location (FDA's records): Suzhou, CN
- FDA decisions: 7 (2018–2026): 7 510(k) clearances
- Product codes: LOX (3), LIT (3), DYB (1)
- 510(k) review time since 2016: median 219 days, against 122 for FDA's reviews in the same codes and years (2 of 7 faster)
- Predicates its devices cite: 6 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Boston Scientific Corp: 2 (https://510kreport.com/company/boston-scientific)
- Orbusneich Medical Trading, Inc.: 1 (https://510kreport.com/company/orbusneich-medical-trading)
- Orbusneich Medical, Inc.: 1 (https://510kreport.com/company/orbusneich-medical)
- Cordis Corp.: 1 (https://510kreport.com/company/cordis)
- C.R. Bard, Inc.: 1 (https://510kreport.com/company/cr-bard)

## Recent decisions
- K262674: Giranel Guiding Sheath Set (Oct 15, 2026)
- K254212: NC PTA Balloon Dilatation Catheter (Sep 16, 2026)
- K231402: HP PTA Balloon Dilatation Catheter (Dec 20, 2023)
- K221245: PTA Balloon Dilatation Catheter (Dec 14, 2022)
- K211349: Selebrek PTCA Balloon Dilatation Catheter (Jan 7, 2022)
- K211393: Selethru (TM) NC PTCA Balloon Dilatation Catheter (Jul 2, 2021)
- K182699: Selethru PTCA Balloon Dilatation Catheter (Nov 26, 2018)

Source page: https://510kreport.com/company/kossel-medtech-suzhou