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

Dilator, Vessel

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

FKA is the FDA product code for Dilator, Vessel, a class II device type, regulated under 21 CFR 876.5540. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
FKA
Device name
Dilator, Vessel
Regulation
21 CFR 876.5540
Device class
Class II
Review panel
Gastroenterology, Urology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
3
Ingested recalls
0

Clearances, product code FKA

By decision year
3 clearances under product code FKA with a decision year between 1991 and 2002, 1991 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code FKA by decision year
YearClearances
19911
19931
20021

Applicants with the most clearances

Product code FKA
Applicants holding the most 510(k) clearances under product code FKA
ApplicantClearances
Akcess Medical Products, Inc.1
Spire Biomedical, Inc.1
Vas-Cath, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code