Microfilter, Blood Transfusion

FDA product code CAK · 36 cleared devices

Class 2 General Hospital

Regulation: 21 CFR 880.5440
Review panel: HO
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1976-08-06 – 2006-05-17

CAK 2006-05-17

HAEMONETICS 40U RBC FILTER BAG

Applicant Haemonetics Corp.

K number K061103

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CAK 2002-10-25

SUMMIT MEDICAL LTD TRANSFUSION FILTER, MODEL LF400 & SUMMIT MEDICAL LTD TRANSFUSION FILTER WITH ADMINISTRATION SET

Applicant Summit Medical , Ltd.

K number K022477

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CAK 2000-05-30

NEOCARE 20 MICRON BLOOD FILTER

Applicant Whatman, Inc.

K number K000719

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CAK 1999-08-30

CHARTER MEDICAL, LTD MP 450 (40 MICRON FILTER)

Applicant Charter Medical, Ltd.

K number K990310

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CAK 1998-09-30

FENWAL 20 MICRON PEDIATRIC TRANSFUSION FILTER MODEL 4C7701, FENWAL 20 MICRON PEDIATRIC TRANSFUSION FILTER SET MODEL 4C72

Applicant Baxter Healthcare Corp

K number K982822

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CAK 1997-07-23

FENWAL 40 MICRON TRANSFUSION FILTER

Applicant Baxter Healthcare Corp

K number K972159

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CAK 1997-02-14

ALPHA MICRON 20/40 MICROAGGREGATE FILTER

Applicant Alpha Therapeutic Corp.

K number K970225

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CAK 1996-04-22

PALL SQ40S BLOOD FILTER (SQ40S/SQ40ST)

Applicant Pall Biomedical Products Co.

K number K960993

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CAK 1996-02-12

ALPHA MICRON 20 MICROAGGREGATE FILTER

Applicant Alpha Therapeutic Corp.

K number K955515

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CAK 1990-10-26

SEPACELL(R) R-200/500 LEUKOCYTE REMOVAL RECIP SETS

Applicant Baxter Healthcare Corp

K number K904223

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CAK 1990-10-26

SEPACELL(R) PL-5A/10A LEUKOCYTE REMOVAL FILTERS

Applicant Baxter Healthcare Corp

K number K904221

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CAK 1990-08-08

MODIFIED SEPACELL R-SERIES BLOOD FILTERS

Applicant Asahi Medical Co., Ltd.

K number K901887

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CAK 1990-02-01

SOLCOSEPT(TM) BLOOD TRANSFUSION FILTER

Applicant Solco Basle, Inc.

K number K896203

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CAK 1990-01-24

MODIFIED SEPACELL R-500 AND R-500A BLOOD FILTERS

Applicant Asahi Medical Co., Ltd.

K number K896976

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CAK 1990-01-24

MODIFIED SEPACELL PL-SERIES LEUKOCYTE REMOVAL FILT

Applicant Asahi Medical Co., Ltd.

K number K896664

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CAK 1989-06-07

MICROSEPT 60/20

Applicant Arbor Technologies, Inc.

K number K890844

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CAK 1988-01-19

SEPACELL R-500 AND SEPACELL R-500A

Applicant Advocacy International, Ltd.

K number K873792

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CAK 1988-01-06

PALL LEUKOCYTE REMOVAL FILTER, PLATELETS

Applicant Pall Biomedical Products Co.

K number K873667

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CAK 1988-01-06

PALL LEUKOCYTE REMOVAL FILTER, BLOOD

Applicant Pall Biomedical Products Co.

K number K873666

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CAK 1987-10-22

RESUBMITTED MICRON TRANSFUSION FILTER

Applicant Travenol Laboratories, S.A.

K number K873873

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CAK 1987-01-14

ERYPUR B

Applicant Organon Teknika Corp.

K number K864636

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CAK 1986-03-12

SWANK BLOOD TRANSFUSION MICRO-FILTER W/STRAIGHT SE

Applicant Cobe Laboratories, Inc.

K number K855064

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CAK 1986-01-08

SEPACELL R-500 & SEPACELL R-500A

Applicant Advocacy International, Ltd.

K number K854259

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CAK 1985-06-27

INTERFACE TRANSFUSION BLOOD FILTER #35

Applicant Medical, Inc.

K number K851370

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CAK 1983-01-26

20 MICRON HIGH CAPACITY TRANS/FILTER

Applicant Travenol Laboratories, S.A.

K number K830057

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CAK 1983-01-17

HEMA - NV TRANS. BLOOD FILTER 100/800

Applicant Abbott Laboratories

K number K830014

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CAK 1983-01-07

INTERFACE TRANSFUSION BLOOD FILTER #30

Applicant Medical, Inc.

K number K823261

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CAK 1981-11-02

PEDIATRIC MICROAGGREGATE BLOOD FILTER

Applicant Abbott Laboratories

K number K812874

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CAK 1981-10-08

HEMA 20 MICRON TRANSFUSION BLOOD FILTER

Applicant Abbott Laboratories

K number K812697

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CAK 1981-07-28

ULTIPOR SQ40S BLOOD TRANSFUSION FILTER

Applicant Pall Biomedical Products Co.

K number K811985

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CAK 1981-06-30

ALPHA MICRON-40 FILTER

Applicant Alpha Therapeutic Corp.

K number K810761

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CAK 1981-04-21

INTERFACE 20 MICRON TRANSFUSION BLD. F.

Applicant Abbott Laboratories

K number K810855

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CAK 1978-02-02

BLOOD FILTER, MICROEMBOLI-ATS-F10

Applicant Sorensen Research

K number K780145

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CAK 1977-04-05

MICROFILTRATION SET MF10

Applicant Biotest-Serum-Institut

K number K770253

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CAK 1976-08-06

FILTER, TRANSFUSION BLOOD, INTERSEPT

Applicant Surgikos, Inc.

K number K760222

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CAK 1976-08-06

FILTER, INFUSION BLOOD (1 PFF-100)

Applicant Bentley Laboratories, Inc.

K number K760165

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