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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
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DUNS Number
560219894

Catalogue (135)

Page 3 of 3
DeviceModel / ReferenceRegistriesClassStatus
Selethru NC PTCA Balloon Dilatation Catheter KNC225012
FDA UDI
Class IIActive
Selethru NC PTCA Balloon Dilatation Catheter KNC400006
FDA UDI
Class IIActive
Selethru NC PTCA Balloon Dilatation Catheter KNC450012
FDA UDI
Class IIActive
Selethru PTCA Balloon Dilatation Catheter KPTCA325030
FDA UDI
Class IIActive
Selethru NC PTCA Balloon Dilatation Catheter KNC500015
FDA UDI
Class IIActive
Selethru NC PTCA Balloon Dilatation Catheter KNC250015
FDA UDI
Class IIActive
Selethru PTCA Balloon Dilatation Catheter KPTCA275020
FDA UDI
Class IIActive
Selethru NC PTCA Balloon Dilatation Catheter KNC200030
FDA UDI
Class IIActive
Selethru PTCA Balloon Dilatation Catheter KPTCA250020
FDA UDI
Class IIActive
Selethru NC PTCA Balloon Dilatation Catheter KNC500008
FDA UDI
Class IIActive
Selethru PTCA Balloon Dilatation Catheter KPTCA275010
FDA UDI
Class IIActive
Selethru PTCA Balloon Dilatation Catheter KPTCA275015
FDA UDI
Class IIActive
Falspeed PTA Balloon Dilatation Catheter KPTA20020L
FDA UDI
Class IIActive
Selethru NC PTCA Balloon Dilatation Catheter KNC200006
FDA UDI
Class IIActive
Selethru PTCA Balloon Dilatation Catheter KPTCA350010
FDA UDI
Class IIActive
Selethru PTCA Balloon Dilatation Catheter KPTCA200015
FDA UDI
Class IIActive
Selethru PTCA Balloon Dilatation Catheter KPTCA225015
FDA UDI
Class IIActive
Selethru NC PTCA Balloon Dilatation Catheter KNC350012
FDA UDI
Class IIActive
Selethru NC PTCA Balloon Dilatation Catheter KNC325030
FDA UDI
Class IIActive
Selethru NC PTCA Balloon Dilatation Catheter KNC225025
FDA UDI
Class IIActive
Selethru NC PTCA Balloon Dilatation Catheter KNC350030
FDA UDI
Class IIActive
Selethru NC PTCA Balloon Dilatation Catheter KNC300015
FDA UDI
Class IIActive
Selethru NC PTCA Balloon Dilatation Catheter KNC400015
FDA UDI
Class IIActive
Selethru NC PTCA Balloon Dilatation Catheter KNC350010
FDA UDI
Class IIActive
Selethru NC PTCA Balloon Dilatation Catheter KNC375010
FDA UDI
Class IIActive
Selethru NC PTCA Balloon Dilatation Catheter KNC375012
FDA UDI
Class IIActive
Selethru NC PTCA Balloon Dilatation Catheter KNC325012
FDA UDI
Class IIActive
Selethru NC PTCA Balloon Dilatation Catheter KNC300006
FDA UDI
Class IIActive
Selethru NC PTCA Balloon Dilatation Catheter KNC200010
FDA UDI
Class IIActive
Selethru NC PTCA Balloon Dilatation Catheter KNC225020
FDA UDI
Class IIActive
HP PTA Balloon Dilatation Catheter K231402
FDA 510(k)
Class IIActive
Selethru PTCA Balloon Dilatation Catheter K182699
FDA 510(k)
Class IIActive
PTA Balloon Dilatation Catheter K221245
FDA 510(k)
Class IIActive
Selebrek PTCA Balloon Dilatation Catheter K211349
FDA 510(k)
Class IIActive
Selethru(TM) NC PTCA Balloon Dilatation Catheter K211393
FDA 510(k)
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