Medical Device Manufacturer · SE , Uppsala

St. Jude Medical Systems AB - FDA 510(k) Cleared Devices

5 submissions · 5 cleared · Since 2011

Recent clearances: PRESSUREWIRE: AERIS AGILE TIP, AERIS AGILE TIP 300, CERTUS AGILE TIP, CERTUS AGILE TIP 300, PRESSUREWIRE AERIS AGILE TIP, PRESSUREWIRE

View 5 510(k) Devices ↓

5

Total

5

Cleared

0

Denied

FDA 510(k) Regulatory Record - St. Jude Medical Systems AB Cardiovascular ✕

5 devices

1-5 of 5

Cleared Nov 13, 2014

PRESSUREWIRE: AERIS AGILE TIP, AERIS AGILE TIP 300, CERTUS AGILE TIP, CERTUS...

Cardiovascular · 262d

Cleared Dec 20, 2013

PRESSUREWIRE AERIS AGILE TIP

Cardiovascular · 29d

Cleared Sep 05, 2013

Cardiovascular · 108d

Cleared Oct 21, 2011

AO USB RECEIVER, WI-BOX, WI-BOX PSU KIT, WI-BOX XPRESS CABLE, PW USB RECEIVER

Cardiovascular · 114d

Cleared Feb 24, 2011

FEMOSTOP PLYS, FEMOSTOP HD, FEMOSTOP COMPRESSION ARCH

Cardiovascular · 31d