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

Hemodialysis Catheter Luer End Cap

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

PEH is the FDA product code for Hemodialysis Catheter Luer End Cap, a class II device type, regulated under 21 CFR 876.5540. FDA's definition for this code reads: "For use in hemodialysis catheters to reduce hub infection". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
PEH
Device name
Hemodialysis Catheter Luer End Cap
FDA definition
For use in hemodialysis catheters to reduce hub infection.
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
No
Ingested clearances
2
Ingested recalls
1

Clearances, product code PEH

By decision year
2 clearances under product code PEH with a decision year between 2013 and 2018, 2013 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code PEH by decision year
YearClearances
20131
20181

Applicants with the most clearances

Product code PEH
Applicants holding the most 510(k) clearances under product code PEH
ApplicantClearances
Pursuit Vascular, Inc.2

Companies listing this code with FDA

Companies whose registered establishments list this code