PULSTA™ Transcatheter Pulmonary Valve System, product family

by Taewoong Medicaland 1 other manufacturer record 14 variants Basic UDI-DI 880964375TPVWW

Shared by every variant

Manufacturer: Taewoong Medical(13)Taewoong Medical Co., Ltd.(1)
Several manufacturer records share this Basic UDI-DI.
Basic UDI-DI: 880964375TPVWW
Risk class: Class III
Legislation: MDR
EMDN category: STENTED BIOLOGICAL PULMONARY VALVES FOR PERCUTANEOUS IMPLANT - VALVE TISSUE OF ANIMAL ORIGIN
Market status: 14 on the market
Official record: EUDAMED public site — Open the EUDAMED public site, choose Devices, and search for the Basic UDI-DI 880964375TPVWW.

Certificates

1 certificate naming this Basic UDI-DI · EUDAMED

MDR 796279 Technical documentation · refdata.applicable-legislation.mdr issued
Notified body 2797 · holder Taewoong Medical Co., Ltd. · issued 21 Jan 2026 · expires 20 Jan 2031

Recalls

0 recalls · FDA

No recall matched the devices on this page.

Recalls matched to the 14 devices listed on this page; other pages of the family can carry others.

Variants

14 devices · page 1 of 1

Variants of PULSTA™ Transcatheter Pulmonary Valve System, Basic UDI-DI 880964375TPVWW
		UDI-DI	Size and differences
PULSTA™ Transcatheter Pulmonary Valve System Taewoong Medical Co., Ltd.	TPV1828 / TPV1828	08809643759854	—	On the market
PULSTA™ Transcatheter Pulmonary Valve System Taewoong Medical	TPV1838 / TPV1828	08809643759632	—	On the market
PULSTA™ Transcatheter Pulmonary Valve System Taewoong Medical	TPV2028 / TPV1828	08809643759861	—	On the market
PULSTA™ Transcatheter Pulmonary Valve System Taewoong Medical	TPV2038 / TPV1828	08809643759649	—	On the market
PULSTA™ Transcatheter Pulmonary Valve System Taewoong Medical	TPV2231 / TPV1828	08809643759878	—	On the market
PULSTA™ Transcatheter Pulmonary Valve System Taewoong Medical	TPV2238 / TPV1828	08809643759656	—	On the market
PULSTA™ Transcatheter Pulmonary Valve System Taewoong Medical	TPV2431 / TPV1828	08809643759885	—	On the market
PULSTA™ Transcatheter Pulmonary Valve System Taewoong Medical	TPV2438 / TPV1828	08809643759663	—	On the market
PULSTA™ Transcatheter Pulmonary Valve System Taewoong Medical	TPV2633 / TPV1828	08809643759892	—	On the market
PULSTA™ Transcatheter Pulmonary Valve System Taewoong Medical	TPV2638 / TPV1828	08809643759670	—	On the market
PULSTA™ Transcatheter Pulmonary Valve System Taewoong Medical	TPV2833 / TPV1828	08809643759908	—	On the market
PULSTA™ Transcatheter Pulmonary Valve System Taewoong Medical	TPV2838 / TPV1828	08809643759687	—	On the market
PULSTA™ Transcatheter Pulmonary Valve System Taewoong Medical	TPV3038 / TPV1828	08809643759694	—	On the market
PULSTA™ Transcatheter Pulmonary Valve System Taewoong Medical	TPV3238 / TPV1828	08809643759700	—	On the market