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

Cannula, A-V Shunt

21 CFR 876.5540 / Gastroenterology, Urology
FDA source (opens on fda.gov)

FIQ is the FDA product code for Cannula, A-V Shunt, a class II device type, regulated under 21 CFR 876.5540. As of , FDA records hold 23 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
FIQ
Device name
Cannula, A-V Shunt
Regulation
21 CFR 876.5540
Device class
Class II
Review panel
Gastroenterology, Urology
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
23
Ingested recalls
0

Clearances, product code FIQ

By decision year
23 clearances under product code FIQ with a decision year between 1977 and 1989, 1983 the highest year at 5.
Show the numbers
510(k) clearances under FDA product code FIQ by decision year
YearClearances
19771
19781
19791
19801
19814
19821
19835
19845
19851
19893

Applicants with the most clearances

Product code FIQ
Applicants holding the most 510(k) clearances under product code FIQ
ApplicantClearances
Renal Systems, Inc.6
Akcess Medical Products, Inc.3
Vas-Cath of Canada, Ltd.3
Med-West, Inc.2
Quinton, Inc.2
Bentley Laboratories, Inc.1
Dow Corning Corp. Healthcare Industries Materials1
Exo, Inc.1
Extracorporeal Medical Specialities, Inc.1
Hospal Medical Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code