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

Catheter, Hemodialysis, Implanted

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

MSD is the FDA product code for Catheter, Hemodialysis, Implanted, a class II device type, regulated under 21 CFR 876.5540. As of , FDA records hold 124 510(k) clearances under this code, the most recent dated , and 270 recalls.

Classification record

Product code
MSD
Device name
Catheter, Hemodialysis, Implanted
Regulation
21 CFR 876.5540
Device class
Class II
Review panel
Gastroenterology, Urology
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
Yes
GMP exempt
No
Third party review eligible
No
Ingested clearances
124
Ingested recalls
270

Clearances, product code MSD

By decision year
124 clearances under product code MSD with a decision year between 1998 and 2025, 2004 the highest year at 16.
Show the numbers
510(k) clearances under FDA product code MSD by decision year
YearClearances
19984
19993
20001
200110
20029
200311
200416
20056
20065
20077
20083
20096
20104
20117
20122
20135
20148
20151
20162
20172
20182
20191
20204
20214
20251

Applicants with the most clearances

Product code MSD
Applicants holding the most 510(k) clearances under product code MSD
ApplicantClearances
Medcomp13
Spire Biomedical, Inc.13
Boston Scientific Corporation12
C.R. Bard Inc11
Medical Components, Inc.10
Kendall9
Marvao Medical Devices Ltd.7
Arrow International LLC (subsidiary of Teleflex Incorporated)4
Medtronic, Inc.3
Merit Medical Systems, Inc.3

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 49 companies shown, in name order