Is this your brand? Sign in to claim ownership.

Sign in to claim this brand

Kossel Medtech (Suzhou) Co., Ltd.

US

Last updated May 23, 2026

What Kossel Medtech (Suzhou) Co., Ltd. makes

The company manufactures coronary angioplasty balloon catheters designed for percutaneous transluminal coronary angioplasty (PTCA), including non-compliant (NC) and standard variants. These devices are intended for dilating narrowed coronary arteries to restore blood flow, with some models incorporating perfusion capabilities to maintain blood supply during the procedure.

The portfolio includes devices classified as Class II and Class III under regulatory frameworks, with authorisations granted through FDA 510(k) submissions and FDA Unique Device Identification (UDI) listings. The company is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country
US
Address
—
Website
—
LinkedIn
—
Facebook
—
Email
—
Phone
—
PRRC Contact
—
EUDAMED SRN
—
FDA FEI Number
—
DUNS Number
560219894

Catalogue (135)

Page 1 of 3
DeviceModel / ReferenceRegistriesClassStatus
Selethru NC PTCA Balloon Dilatation Catheter KNC300030
FDA UDI
Class IIActive
Selethru PTCA Balloon Dilatation Catheter KPTCA325025
FDA UDI
Class IIActive
Selethru NC PTCA Balloon Dilatation Catheter KNC275010
FDA UDI
Class IIActive
Selethru NC PTCA Balloon Dilatation Catheter KNC400030
FDA UDI
Class IIActive
Selethru PTCA Balloon Dilatation Catheter KPTCA400020
FDA UDI
Class IIActive
Selethru PTCA Balloon Dilatation Catheter KPTCA300015
FDA UDI
Class IIActive
Selethru NC PTCA Balloon Dilatation Catheter KNC225008
FDA UDI
Class IIActive
Selethru NC PTCA Balloon Dilatation Catheter KNC350008
FDA UDI
Class IIActive
Selethru PTCA Balloon Dilatation Catheter KPTCA200025
FDA UDI
Class IIActive
Selethru NC PTCA Balloon Dilatation Catheter KNC450010
FDA UDI
Class IIActive
Selethru PTCA Balloon Dilatation Catheter KPTCA350015
FDA UDI
Class IIActive
Selethru PTCA Balloon Dilatation Catheter KPTCA250025
FDA UDI
Class IIActive
Selethru NC PTCA Balloon Dilatation Catheter KNC500006
FDA UDI
Class IIActive
Selethru NC PTCA Balloon Dilatation Catheter KNC375006
FDA UDI
Class IIActive
Selethru NC PTCA Balloon Dilatation Catheter KNC375030
FDA UDI
Class IIActive
Selethru NC PTCA Balloon Dilatation Catheter KNC450015
FDA UDI
Class IIActive
Selethru PTCA Balloon Dilatation Catheter KPTCA400025
FDA UDI
Class IIActive
Selethru PTCA Balloon Dilatation Catheter KPTCA275030
FDA UDI
Class IIActive
Selethru PTCA Balloon Dilatation Catheter KPTCA275025
FDA UDI
Class IIActive
Selethru PTCA Balloon Dilatation Catheter KPTCA300025
FDA UDI
Class IIActive
Selethru NC PTCA Balloon Dilatation Catheter KNC250012
FDA UDI
Class IIActive
Selethru NC PTCA Balloon Dilatation Catheter KNC275012
FDA UDI
Class IIActive
Selethru PTCA Balloon Dilatation Catheter KPTCA250010
FDA UDI
Class IIActive
Selethru NC PTCA Balloon Dilatation Catheter KNC300025
FDA UDI
Class IIActive
Selethru PTCA Balloon Dilatation Catheter KPTCA150020
FDA UDI
Class IIActive
Selethru NC PTCA Balloon Dilatation Catheter KNC250030
FDA UDI
Class IIActive
Selethru NC PTCA Balloon Dilatation Catheter KNC450020
FDA UDI
Class IIActive
Selethru PTCA Balloon Dilatation Catheter KPTAC200030
FDA UDI
Class IIActive
Selethru NC PTCA Balloon Dilatation Catheter KNC350025
FDA UDI
Class IIActive
Selethru NC PTCA Balloon Dilatation Catheter KNC300010
FDA UDI
Class IIActive
Selethru NC PTCA Balloon Dilatation Catheter KNC250008
FDA UDI
Class IIActive
Selethru NC PTCA Balloon Dilatation Catheter KNC225030
FDA UDI
Class IIActive
Selethru NC PTCA Balloon Dilatation Catheter KNC250020
FDA UDI
Class IIActive
Selethru NC PTCA Balloon Dilatation Catheter KNC500010
FDA UDI
Class IIActive
Selethru PTCA Balloon Dilatation Catheter KPTCA400010
FDA UDI
Class IIActive
Selethru PTCA Balloon Dilatation Catheter KPTCA225020
FDA UDI
Class IIActive
Selethru PTCA Balloon Dilatation Catheter KPTCA225025
FDA UDI
Class IIActive
Selethru NC PTCA Balloon Dilatation Catheter KNC200012
FDA UDI
Class IIActive
Selethru PTCA Balloon Dilatation Catheter KPTCA300010
FDA UDI
Class IIActive
Selethru NC PTCA Balloon Dilatation Catheter KNC375025
FDA UDI
Class IIActive
Selethru NC PTCA Balloon Dilatation Catheter KNC375015
FDA UDI
Class IIActive
Selethru PTCA Dilatation Balloon Catheter KPTCA150025
FDA UDI
Class IIActive
Selethru PTCA Balloon Dilatation Catheter KPTCA225030
FDA UDI
Class IIActive
Selethru PTCA Balloon Dilatation Catheter KPTCA350030
FDA UDI
Class IIActive
Selethru NC PTCA Balloon Dilatation Catheter KNC325006
FDA UDI
Class IIActive
Selethru PTCA Balloon Dilatation Catheter KPTCA325015
FDA UDI
Class IIActive
Selethru NC PTCA Balloon Dilatation Catheter KNC450008
FDA UDI
Class IIActive
Selethru NC PTCA Balloon Dilatation Catheter KNC325025
FDA UDI
Class IIActive
Selethru PTCA Balloon Dilatation Catheter KPTCA350020
FDA UDI
Class IIActive
Selethru NC PTCA Balloon Dilatation Catheter KNC275020
FDA UDI
Class IIActive

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

  • Kossel Medtech (suzhou) Co., Ltd. Suzhou Jiangsu · CN FEI 3014390222