ClearanceBrief
Panels › Gastroenterology, Urology › Product code MPB · Class 2

Catheter, Hemodialysis, Non-Implanted

Regulation 876.5540

0510(k)s in 12 months (38 all time)
4recalls in 12 months (24 all time)
23recalls that name a 510(k)
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Top companies in MPB

DateFirm and productCodeLinked 510(k)
Sep 11, 2026Bard Access Systems, Inc.
DuoGlide Short-Term Straight Dialysis Catheter, REF: 5625150; DuoGlide Short-Term Straight Dialysis Catheter, REF: 5625200; DuoGlide Short-Term Straight Dialysis Catheter, REF: 5625240; DuoGlide Short
Open, Classified
MPBK030268
K090102
Sep 11, 2026Bard Access Systems, Inc.
Power-Trialysis Short-Term Straight Dialysis Catheter, REF: 5605150; Power-Trialysis Short-Term Straight Dialysis Catheter, REF: 5605200; Power-Trialysis Short-Term Straight Dialysis Catheter, REF:
Open, Classified
MPBK133456
K141531
Jun 13, 2026ARROW INTERNATIONAL, LLC
Description/REF: HEMODIALYSIS KIT: 2-LUMEN 8 FR X 11 CM/AK-11802-F; HEMODIALYSIS KIT: 2-LUMEN 12 FR X 16 CM/AK-22122; HEMODIALYSIS KIT 2L: 14 FR X 15CM AGB/AK-22142-CDC; HEMODIALYSIS KIT 2L: 14 FR X 2
Open, Classified
MPBK984022
K993933
Jun 5, 2026Mozarc Medical US LLC
Mahurkar Elite PASS Trays; Description (Product Number/CFN): 12 FR x 13cm Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888221413), 12 FR x 16cm Acute Dual Lumen Catheter with Curved
Open, Classified
MPBK120674
Jul 12, 2018Medical Components, Inc dba MedComp
DUO FLOW DOUBLE LUMEN CATHETER, XTP114CT, XTP114MT, ; RAULERSON DUO FLOW IJ DOUBLE LUMEN CATHETER/CATHETER SET, XTP114IJC, XTP114IJS, XTP114IJSE, XTP114MT-C, XTP116IJC, XTP116IJS, XTP116IJSE RAULERSON
Terminated
MPBK842416
K983511
Jul 12, 2018Medical Components, Inc dba MedComp
DUO FLOW CUSTOM TRAYS; TRAY #414 TRAY #415 TRAY #67
Terminated
MPBK842416
K983511
Jul 12, 2018Medical Components, Inc dba MedComp
SOFT-LINE DUO-FLOW DOUBLE LUMEN CATHETER/CATHETER SET; T94C T94M T96M T98M
Terminated
MPBK842416
K983511
Jul 12, 2018Medical Components, Inc dba MedComp
SOFT-LINE DUO-FLOW DOUBLE LUMEN CATHETER TRAY; T3500 T4000 T4400 T4424
Terminated
MPBK842416
K983511
Jul 12, 2018Medical Components, Inc dba MedComp
Duo-Flow Double Lumen Catheter Only/Catheter Set; T114C T114M T116C T116M T116ME T118C T118M T118ME T119M
Terminated
MPBK842416
K983511
Jul 12, 2018Medical Components, Inc dba MedComp
Duo-Flow XTP Straight Full Set, RMS02105 RMS02108
Terminated
MPBK842416
K983511
Jul 12, 2018Medical Components, Inc dba MedComp
Duo-Flow Catheter Full Tray; MCDLT3500 MCDLT4000 MCDLT4400 MCDLT4424# Hemodialysis catheter insertion kits
Terminated
MPBK842416
K983511
Jul 12, 2018Medical Components, Inc dba MedComp
Duo-Flow IJ Full Tray; MCDLT114IJ MCDLT116IJ MCDLT118IJ
Terminated
MPBK842416
K983511
Jul 12, 2018Medical Components, Inc dba MedComp
Duo-Flow Double Lumen Soft Tip CRRT/ABP Catheter Set; DL11/24 . Hemodialysis catheter insertion kits
Terminated
MPBK842416
K983511
Jul 12, 2018Medical Components, Inc dba MedComp
Double Lumen CRRT/ABP Catheter Set; Hemodialysis catheter insertion kits, DL 11/15 DL 11/20 DL 9/15
Terminated
MPBK842416
K983511
Jul 12, 2018Medical Components, Inc dba MedComp
Duo-Flow XTP Straight Full Set; Hemodialysis catheter insertion kits, AAC02106 AAC02107 AAC02108
Terminated
MPBK842416
K983511
Feb 20, 2018Arrow International Inc
ARROWg+ard Blue Two Lumen Hemodialysis Catheterization Kit for High Volume Infusions; Product Codes: AK-22142-CDC, AK-22142-F, AK-25142-CDC, AK-25142-F; Exp. Dates Feb 2018 - Nov 2018
Terminated
MPBK993933
Dec 22, 2017Arrow International Inc
ARROWg+ard Blue Two-Lumen Hemodialysis Catheterization Kit for High Volume Infusions (1) Part Number (PN): CDC-22122-1A; (2) PN: CDC-25122-1A; (3) PN: CDC-25142-1A; (4) CDC-26142-1A
Terminated
MPBK993933
Oct 14, 2017Medtronic Minimally Invasive Therapies Group
MAHURKAR"* Elite 12 FR x 16cm Acute Dual Lumen Dialysis Catheter with Curved Extensions, IC Trays. Product Number: 8888222316.
Terminated
MPBK120674
May 9, 2017Arrow International Inc
1) ARROWg+ard Blue You-Blend Two-Lumen Hemodialysis Catheterization Kit for High Volume Infusions The large-bore two-lumen catheter permits venous access to the central circulation for rapid fluid ad
Terminated
MPBK993933
Aug 18, 2015Cordis Corporation
RenLane Renal Denervation Catheter; Cat No.: D135601. Used in adults patients (>18 years) with drug resistant hypertension to denervate the renal arteries to reduce blood pressure.
Terminated
MPBNone listed
Sep 20, 2007C.R. Bard Access Systems, Inc
Guidewire, 70cm x 1mm, REF 5583705, Sterile, Single Use, BARD Access Systems, Hemodialysis Catheter, Salt Lake City, UT 84116.
Terminated
MPBK844433
Jul 20, 2004Arrow International Inc
Two Lumen 14F Hemodialysis Catheter Kits/Sets with Blue FlexTip Arrowg+ard Blue Curved Catheter for high Volume Ifusions
Terminated
MPBK991431
K993933
Dec 17, 2003Kendall Healthcare Products Co
Mahurkar QPlus Dual Lumen Catheter Insertion Tray with Curved Extension, 13.5 Fr/Ch x 19.5cm For hemodialysis, apheresis, and infusion Reference: 8888-135195
Terminated
MPBK030209
Dec 17, 2003Kendall Healthcare Products Co
Mahurkar QPlus Dual Lumen Catheter Kit with Curved Extension, 13.5 Fr/Ch x 19.5cm For hemodialysis, apheresis, and infusion. Reference: 8888-135192
Terminated
MPBK030209

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