Medical Device Manufacturer · US , Rockville , MD

Asahi Kasei Medical Co., Ltd. - FDA 510(k) Cleared Devices

5 submissions · 5 cleared · Since 2005

5

Total

5

Cleared

0

Denied

FDA 510(k) Regulatory Record - Asahi Kasei Medical Co., Ltd. Gastroenterology & Urology ✕

5 devices

1-5 of 5

Cleared May 03, 2017

Asahi ViE-U Series Dialyzer

Gastroenterology & Urology · 266d

Cleared Dec 17, 2015

Asahi REXEED-S Series Dialyzer

Gastroenterology & Urology · 28d

Cleared Feb 06, 2013

ASAHI REXEED-SX/LX SERIES DIALYZER

Gastroenterology & Urology · 271d

Cleared Oct 03, 2008

ASAHI REXEED-SX/LX DIALYZERS, MODELS: 13SX, 15SX, 18SX, 21SX, 25SX, 13LX,...

Gastroenterology & Urology · 31d

Cleared Jun 08, 2005

REXEED SERIES DIALYZERS

Gastroenterology & Urology · 30d