Regulatory Materials - PulseCath

Pulsecath Academy

Regulatory Materials

Regulatory Materials

All regulatory files can be downloaded on the right.

MDR certificates
Certificate_ISO13485_PulseCath_145237-25-02-06_2025-02-06_AZ14654
Certificate_MDR_PulseCath_145213-24-03-01
Certificate_MDR_PulseCath_145214-24-03-01
Certificate_MDR_PulseCath_145213-24-03-01_2025-08-12_AZ14690 (2025)
Certificate_MDR_PulseCath_145214-24-03-01_AZ14689_1 (2025)
Certificate_MDR_PulseCath_145214-24-03-01_AZ14688_2 (2025)
Certificate_MDR_PulseCath_145213-24-03-01_2025-08-12_AZ14691 (2025)
Manufacturer Declaration MDR Extension_2024-06-12
SSCP-iVAC-2L_Master_en-2
IFU and Product Labels
IFU LV17-17
IFU LV17-UA
IFU LV17-12: change membrane pump long driveline (batch 3E01 and on)
Product and Package Labels iVAC 2L_REV4
PulseCath LV17CE-7 – label
Cook Check-Flo Performer Introducer
Magnum 18Fr Sheath IFU 01
Medtronic Sentrant 18Fr Sheath IFU