FDA 510(k)

MODIFIED SEPACELL PL-SERIES LEUKOCYTE REMOVAL FILT

K-Number: K896664 · 1990-01-24

Decision Date1990-01-24

Product CodeCAK

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

MODIFIED SEPACELL PL-SERIES LEUKOCYTE REMOVAL FILT is the device name listed in this FDA 510(k) record. The listed applicant is Asahi Medical Co., Ltd.. It received FDA 510(k) clearance on 1990-01-24 under 510(k) number K896664. The device is classified under product code CAK. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFIED SEPACELL PL-SERIES LEUKOCYTE REMOVAL FILT?

MODIFIED SEPACELL PL-SERIES LEUKOCYTE REMOVAL FILT is a medical device that received FDA 510(k) clearance on 1990-01-24. The listed applicant is Asahi Medical Co., Ltd.. The 510(k) number is K896664.

When did MODIFIED SEPACELL PL-SERIES LEUKOCYTE REMOVAL FILT receive FDA 510(k) clearance?

MODIFIED SEPACELL PL-SERIES LEUKOCYTE REMOVAL FILT received FDA 510(k) clearance on 1990-01-24, under 510(k) number K896664.

Who is the listed applicant for MODIFIED SEPACELL PL-SERIES LEUKOCYTE REMOVAL FILT?

The FDA 510(k) record lists Asahi Medical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFIED SEPACELL PL-SERIES LEUKOCYTE REMOVAL FILT?

The FDA product code for MODIFIED SEPACELL PL-SERIES LEUKOCYTE REMOVAL FILT is CAK.

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Other records listing Asahi Medical Co., Ltd. as applicant

K041726HIGH FLUX HEMODIALYSIS MEMBRANE DIALYZER OR HIGH FLUX HOLLOW FIBER DIALYZER, MODELS APS-R, -M, -S, -E, AND -EX K013418AM-BIO EXTENDED RANGE SERIES DIALYZER, MODELS WET AND DRY K001250APS SERIES DIALYZERS (WET MODELS), APS SERIES DIALYSIS (DRY MODELS)K991512ASAHI AM-R-SERIES DIALYZERS (MODIFIED), MODEL AM-NR-X K983720ASAHI AM-BIO SERIES DIALYZERS (WET MODELS)& (DRY MODELS), MODELS AM-BIO-50,AM-BIO-65, AM-BIO-75, AND AM-BIO-100, AM-BIO-K970650ASAHI AM-R SERIES DIALYZERS

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Related Devices (Code: CAK)

K061103HAEMONETICS 40U RBC FILTER BAGHaemonetics Corp.K022477SUMMIT MEDICAL LTD TRANSFUSION FILTER, MODEL LF400 & SUMMIT MEDICAL LTD TRANSFUSION FILTER WITH ADMINISTRATION SETSummit Medical , Ltd.K000719NEOCARE 20 MICRON BLOOD FILTERWhatman, Inc.K990310CHARTER MEDICAL, LTD MP 450 (40 MICRON FILTER)Charter Medical, Ltd.K982822FENWAL 20 MICRON PEDIATRIC TRANSFUSION FILTER MODEL 4C7701, FENWAL 20 MICRON PEDIATRIC TRANSFUSION FILTER SET MODEL 4C72Baxter Healthcare Corp K972159FENWAL 40 MICRON TRANSFUSION FILTERBaxter Healthcare Corp

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.