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

Catheter, Hemodialysis, Implanted

Regulation 876.5540

0510(k)s in 12 months (124 all time)
8recalls in 12 months (270 all time)
257recalls that name a 510(k)
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Top companies in MSD

Company510(k)sRecalls
Covidien371
Spire Biomedical, Inc.1348
Arrow International, Inc.450
AngioDynamics, Inc.434
Bard Peripheral Vascular, Inc.130
Angiodynamics Worldwide Headquarters016
Medcomp130
C. R. Bard120
Kendall90
Marvao Medical Devices, Ltd.71
DateFirm and productCodeLinked 510(k)
May 13, 2026ARROW INTERNATIONAL, LLC
NextStep Antegrade Chronic Hemodialysis Catheter, REF: AC-15192-SFX, AC-15232-SFX, CS-15192-SFX, CS-15232-SFX, CS-15272-SFX, CS-15312-SFX, CS-15422-SFX, CS-15502-SFX; NextStep Antegrade Hemodialysi
Open, Classified		 MSDK111117
K111900
May 13, 2026ARROW INTERNATIONAL, LLC
Cannon II Plus Hemodialysis Catheter, REF: CS-15242-VSP, CS-15282-VSP, CS-15322-VSP, CS-15362-VSP, CS-15552-VSP, CSD-15242-SP, CSD-15282-SP; Cannon II Plus Hemodialysis Catheter with Arrow Simplicity
Open, Classified		 MSDK111117
May 13, 2026ARROW INTERNATIONAL, LLC
Arrow-Clark VectorFlow Antegrade Chronic Hemodialysis Catheter: REF: ACS-15192-VFI, ACS-15232-VFI, ACS-15272-VFI, CS-15192-VFI, CS-15192-VFIE, CS-15232-VFI, CS-15232-VFIE, CS-15272-VFI, CS-15272-VFIE,
Open, Classified		 MSDK141051
May 13, 2026ARROW INTERNATIONAL, LLC
Arrow Edge Hemodialysis Catheterization Product, REF: CS-15242-I, CS-15282-I, CS-15322-I
Open, Classified		 MSDK111117
Mar 26, 2026Merit Medical Systems, Inc.
BioFlo DuraMax Catheter, REF: H965103028011/A, H965103028021/A, H965103028021/EU, H965103028031/A, H965103028031/EU, H965103028041/A, H965103028041/EU, H965103028051/A, H965103028051/EU, H965103028061
Open, Classified		 MSDK131260
Mar 26, 2026Merit Medical Systems, Inc.
DuraMax Chronic Hemodialysis Catheter, REF: H787103028015/A, H787103028025/A, H787103028031/A, H787103028035/A, H787103028041/A, H787103028045/A, H787103028051/A, H787103028055/A, H787103028061/A, H78
Open, Classified		 MSDK101843
Mar 26, 2026Merit Medical Systems, Inc.
ProGuide Chronic Dialysis Catheters, REF: DC01455550/C, DC21452419/C, DC21452419-NE5/C, DC21452823-NE5/C, DC21454035/C, DC21455550/C
Open, Classified		 MSDK090148
Mar 26, 2026Merit Medical Systems, Inc.
CentrosFLO Hemodialysis Catheters, REF: CENFP15K/A, CENFP15K/B, CENFP17K/A, CENFP19K/A, CENFP23K/A, CENFP27K/A, CENFP31K/A, CENFT15K, CENFT15K/D, CENFT17K, CENFT17K/A, CENFT17K/D, CENFT19K, CENFT19K/A
Open, Classified		 MSDK151967
May 30, 2025Mozarc Medical US LLC
MAHURKAR Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
Open, Classified		 MSDK123196
May 30, 2025Mozarc Medical US LLC
Palindrome Precision H Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
Open, Classified		 MSDK123196
May 30, 2025Mozarc Medical US LLC
Palindrome Precision SI Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
Open, Classified		 MSDK123196
May 30, 2025Mozarc Medical US LLC
Palindrome Precision HSI Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
Open, Classified		 MSDK123196
May 30, 2025Mozarc Medical US LLC
Palindrome Precision Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
Open, Classified		 MSDK123196
May 3, 2024Angiodynamics, Inc.
BioFlo DuraMax 15.5F 24cm Single Valve Sheath VascPak Kit- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H965103038181
Open, Classified		 MSDK131260
May 3, 2024Angiodynamics, Inc.
DURAMAX STACKED TIP 32 CM STRAIGHT VASC-PAK, 1-UP PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103028201
Open, Classified		 MSDK101843
May 3, 2024Angiodynamics, Inc.
DURAMAX STACKED TIP 28 CM STRAIGHT VASC-PAK, 5-UP PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103028195
Open, Classified		 MSDK101843
May 3, 2024Angiodynamics, Inc.
DURAMAX STACKED TIP 28 CM STRAIGHT VASC-PAK, 1-UP PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103028191
Open, Classified		 MSDK101843
May 3, 2024Angiodynamics, Inc.
DURAMAX STACKED TIP 32CM STR. BASIC KIT, 5-UP PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103028055
Open, Classified		 MSDK101843
May 3, 2024Angiodynamics, Inc.
DURAMAX STACKED TIP 28CM STR. BASIC KIT, 5-UP PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103028045
Open, Classified		 MSDK101843
May 3, 2024Angiodynamics, Inc.
DURAMAX STACKED TIP 28CM STR. BASIC KIT, 1-UP PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103028041
Open, Classified		 MSDK101843
May 3, 2024Angiodynamics, Inc.
DURAMAX STACKED TIP 24CM STR. BASIC KIT, 5-UP PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103028035
Open, Classified		 MSDK101843
May 3, 2024Angiodynamics, Inc.
DURAMAX STACKED TIP 24CM STR. BASIC KIT, 1-UP PG Product Number: H787103028031
Open, Classified		 MSDK101843
May 3, 2024Angiodynamics, Inc.
DURAFLOW 2, 28CM STRAIGHT VASC-PAK PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103012195
Open, Classified		 MSDK110936
May 3, 2024Angiodynamics, Inc.
DURAFLOW 2, 24CM STRAIGHT VASC-PAK PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103012185
Open, Classified		 MSDK110936
May 3, 2024Angiodynamics, Inc.
DURAFLOW 2, 55CM STRAIGHT BASIC KIT PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103012115
Open, Classified		 MSDK110936
May 3, 2024Angiodynamics, Inc.
DURAFLOW 2, 32CM STRAIGHT BASIC KIT PG-Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103012035
Open, Classified		 MSDK110936
May 3, 2024Angiodynamics, Inc.
DURAFLOW 2, 28CM STRAIGHT BASIC KIT, 1 per Bx PG-Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103012021
Open, Classified		 MSDK110936
May 3, 2024Angiodynamics, Inc.
DURAFLOW 2, 24CM STRAIGHT BASIC KIT -Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103012015
Open, Classified		 MSDK110936
Apr 24, 2024Covidien LP
Palindrome Precision H Chronic Catheter Kit 14.5 Fr/Ch (4.8mm) x 23 cm (Symmetrical Tip, Heparin Coating and Tal VenaTrac Stylet- Intended for acute and chronic hemodialysis, apheresis, and infusion
Open, Classified		 MSDK123196
Apr 24, 2024Covidien LP
Palindrome Precision HSI Chronic Catheter Sport Pack 14.5 Fr/Ch (4.8mm) x 19 cm (Symmetrical Tip, Heparin Coating, Silver Ion Sleeve and Tal VenaTrac Stylet- Intended for acute and chronic hemodialy
Open, Classified		 MSDK123196
Sep 25, 2023Covidien LP
Palindrome Chronic Catheter Kit Symmetrical Tip14.5 Fr/Ch(4.8mm)x23cm
Open, Classified		 MSDK111372
Jul 7, 2022Covidien Llc
Mahurkar Chronic Carbothane (Maxid) Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.
Open, Classified		 MSDK111372
Jul 7, 2022Covidien Llc
Palindrome HSI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.
Open, Classified		 MSDK112477
Jul 7, 2022Covidien Llc
Palindrome SI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.
Open, Classified		 MSDK112477
Jul 7, 2022Covidien Llc
Palindrome H Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.
Open, Classified		 MSDK112477
Jul 7, 2022Covidien Llc
Palindrome Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialysis, apheresis, and infusion.
Open, Classified		 MSDK111372
Jul 7, 2022Covidien Llc
Palindrome Precision HSI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.
Open, Classified		 MSDK123196
Jul 7, 2022Covidien Llc
Palindrome Precision SI Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialysis, apheresis, and infusion.
Open, Classified		 MSDK123196
Jul 7, 2022Covidien Llc
Palindrome Precision H Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialysis, apheresis, and infusion.
Open, Classified		 MSDK123196
Jul 7, 2022Covidien Llc
Palindrome Precision Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialysis, apheresis, and infusion.
Open, Classified		 MSDK123196
May 28, 2021Covidien, LP
Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 55 cm, Item Code 8888541055P
Open, Classified		 MSDK123196
May 28, 2021Covidien, LP
Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 44 cm, Item Code 8888541044P
Open, Classified		 MSDK123196
May 28, 2021Covidien, LP
Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 33 cm, Item Code 8888541033P
Open, Classified		 MSDK123196
May 28, 2021Covidien, LP
Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 28 cm, Item Code 8888541028P
Open, Classified		 MSDK123196
May 28, 2021Covidien, LP
Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 23 cm, Item Code 8888541023P
Open, Classified		 MSDK123196
May 28, 2021Covidien, LP
Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 19 cm, Item Code 8888541019P
Open, Classified		 MSDK111817
May 28, 2021Covidien, LP
Palindrome RT Repair Kit 15 FR TAL 55cm, Sterile, Item Code 8888541155
Open, Classified		 MSDK111817
May 28, 2021Covidien, LP
Palindrome RT Repair Kit 15 FR TAL 44cm, Sterile, Item Code 8888541144
Open, Classified		 MSDK111817
May 28, 2021Covidien, LP
Palindrome RT Repair Kit 15 FR TAL 33cm, Sterile, Item Code 8888541133
Open, Classified		 MSDK111817
May 28, 2021Covidien, LP
Palindrome RT Repair Kit 15 FR TAL 28cm, Sterile, Item Code 8888541128
Open, Classified		 MSDK111817

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