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)
Top companies in MPB
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 11, 2026 | Bard 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 |
MPB | K030268 K090102 |
| Sep 11, 2026 | Bard 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 |
MPB | K133456 K141531 |
| Jun 13, 2026 | ARROW 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 |
MPB | K984022 K993933 |
| Jun 5, 2026 | Mozarc 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 |
MPB | K120674 |
| Jul 12, 2018 | Medical 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 |
MPB | K842416 K983511 |
| Jul 12, 2018 | Medical Components, Inc dba MedComp DUO FLOW CUSTOM TRAYS; TRAY #414
TRAY #415
TRAY #67 Terminated |
MPB | K842416 K983511 |
| Jul 12, 2018 | Medical Components, Inc dba MedComp SOFT-LINE DUO-FLOW DOUBLE LUMEN CATHETER/CATHETER SET; T94C
T94M T96M T98M Terminated |
MPB | K842416 K983511 |
| Jul 12, 2018 | Medical Components, Inc dba MedComp SOFT-LINE DUO-FLOW DOUBLE LUMEN CATHETER TRAY;
T3500
T4000
T4400
T4424 Terminated |
MPB | K842416 K983511 |
| Jul 12, 2018 | Medical Components, Inc dba MedComp Duo-Flow Double Lumen Catheter Only/Catheter Set; T114C T114M T116C T116M T116ME T118C T118M T118ME T119M Terminated |
MPB | K842416 K983511 |
| Jul 12, 2018 | Medical Components, Inc dba MedComp Duo-Flow XTP Straight Full Set, RMS02105
RMS02108 Terminated |
MPB | K842416 K983511 |
| Jul 12, 2018 | Medical Components, Inc dba MedComp Duo-Flow Catheter Full Tray; MCDLT3500
MCDLT4000 MCDLT4400 MCDLT4424# Hemodialysis catheter insertion kits Terminated |
MPB | K842416 K983511 |
| Jul 12, 2018 | Medical Components, Inc dba MedComp Duo-Flow IJ Full Tray; MCDLT114IJ
MCDLT116IJ
MCDLT118IJ Terminated |
MPB | K842416 K983511 |
| Jul 12, 2018 | Medical Components, Inc dba MedComp Duo-Flow Double Lumen Soft Tip CRRT/ABP Catheter Set; DL11/24
. Hemodialysis catheter insertion kits Terminated |
MPB | K842416 K983511 |
| Jul 12, 2018 | Medical Components, Inc dba MedComp Double Lumen CRRT/ABP Catheter Set; Hemodialysis catheter insertion kits, DL 11/15
DL 11/20
DL 9/15 Terminated |
MPB | K842416 K983511 |
| Jul 12, 2018 | Medical Components, Inc dba MedComp Duo-Flow XTP Straight Full Set; Hemodialysis catheter insertion kits, AAC02106
AAC02107
AAC02108 Terminated |
MPB | K842416 K983511 |
| Feb 20, 2018 | Arrow 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 |
MPB | K993933 |
| Dec 22, 2017 | Arrow 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 |
MPB | K993933 |
| Oct 14, 2017 | Medtronic Minimally Invasive Therapies Group MAHURKAR"* Elite 12 FR x 16cm Acute Dual Lumen Dialysis
Catheter with Curved Extensions, IC Trays. Product Number: 8888222316. Terminated |
MPB | K120674 |
| May 9, 2017 | Arrow 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 |
MPB | K993933 |
| Aug 18, 2015 | Cordis 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 |
MPB | None listed |
| Sep 20, 2007 | C.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 |
MPB | K844433 |
| Jul 20, 2004 | Arrow International Inc Two Lumen 14F Hemodialysis Catheter Kits/Sets with Blue FlexTip Arrowg+ard Blue Curved Catheter for high Volume Ifusions Terminated |
MPB | K991431 K993933 |
| Dec 17, 2003 | Kendall 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 |
MPB | K030209 |
| Dec 17, 2003 | Kendall 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 |
MPB | K030209 |
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