510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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CAKClass II

Microfilter, Blood Transfusion

21 CFR 880.5440 / General Hospital
FDA source (opens on fda.gov)

CAK is the FDA product code for Microfilter, Blood Transfusion, a class II device type, regulated under 21 CFR 880.5440. As of , FDA records hold 36 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
CAK
Device name
Microfilter, Blood Transfusion
Regulation
21 CFR 880.5440
Device class
Class II
Review panel
General Hospital
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
36
Ingested recalls
1

Clearances, product code CAK

By decision year
36 clearances under product code CAK with a decision year between 1976 and 2006, 1990 the highest year at 6.
Show the numbers
510(k) clearances under FDA product code CAK by decision year
YearClearances
19762
19771
19781
19815
19833
19851
19862
19872
19883
19891
19906
19962
19972
19981
19991
20001
20021
20061

Applicants with the most clearances

Product code CAK
Applicants holding the most 510(k) clearances under product code CAK
ApplicantClearances
Abbott Medical4
Baxter Healthcare Corporation4
Pall Biomedical Products Co.4
Alpha Therapeutic Corp.3
Asahi Kasei Medical MT Corp. Oita Works3
Advocacy International, Ltd.2
Medical, Inc.2
Travenol Laboratories, S.A.2
Arbor Technologies, Inc.1
Bentley Laboratories, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code