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

Catheter, Hemodialysis, Non-Implanted

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

MPB is the FDA product code for Catheter, Hemodialysis, Non-Implanted, a class II device type, regulated under 21 CFR 876.5540. As of , FDA records hold 38 510(k) clearances under this code, the most recent dated , and 22 recalls.

Classification record

Product code
MPB
Device name
Catheter, Hemodialysis, Non-Implanted
Regulation
21 CFR 876.5540
Device class
Class II
Review panel
Gastroenterology, Urology
Submission type
510(k)
Implant
No
Life sustaining or supporting
Yes
GMP exempt
No
Third party review eligible
No
Ingested clearances
38
Ingested recalls
24

Clearances, product code MPB

By decision year
38 clearances under product code MPB with a decision year between 1987 and 2025, 1999 the highest year at 6.
Show the numbers
510(k) clearances under FDA product code MPB by decision year
YearClearances
19871
19881
19891
19901
19951
19962
19972
19996
20002
20011
20033
20041
20073
20091
20101
20112
20121
20131
20161
20172
20203
20251

Applicants with the most clearances

Product code MPB
Applicants holding the most 510(k) clearances under product code MPB
ApplicantClearances
Medical Components, Inc.7
C.R. Bard Inc5
Quinton, Inc.5
Arrow Intl., Inc.3
Medtronic, Inc.2
Gambro Renal Products2
Ameco Medical Industries1
B.Braun Medical, Inc.1
Cook Incorporated1
Cook Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 34 companies shown, in name order