ClearanceBrief
510(k) K101843 ยท MSD Catheter, Hemodialysis, Implanted

DURAMAX CHRONIC HEMODIALYSIS CATHETER AND PROCEDURE KIT

ApplicantAngioDynamics, Inc., Latham NY, US
DecisionUnknown, Oct 20, 2010
ReceivedJul 1, 2010
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K101843

DateFirm and productCodeLinked 510(k)
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
MSDNone listed
May 3, 2024Angiodynamics, Inc.
DURAMAX STACKED TIP 24CM STR. BASIC KIT, 1-UP PG Product Number: H787103028031
Open, Classified
MSDNone listed
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
MSDNone listed
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
MSDNone listed
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
MSDNone listed
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
MSDNone listed
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
MSDNone listed
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
MSDNone listed
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
MSDNone listed
Jan 12, 2012Angiodynamics Worldwide Headquarters
Angiodynamics DuraMax 15.5F x 32 cm Chronic Hemodialysis Catheter Set (with Cuff 27cm from Tip) --- Catalog No. [REF] 10302805 --- MANUFACTURED IN USA AngioDynamics, Inc., 603 Queensbury Avenue, Queen
Terminated
MSDNone listed
Jan 12, 2012Angiodynamics Worldwide Headquarters
Angiodynamics DuraMax 15.5F x 22 cm Chronic Hemodialysis Catheter Set (with Cuff 17cm from Tip) --- Catalog No. [REF] 10302802 --- MANUFACTURED IN USA AngioDynamics, Inc., 603 Queensbury Avenue, Queen
Terminated
MSDNone listed
Jan 12, 2012Angiodynamics Worldwide Headquarters
Angiodynamics DuraMax 15.5F x 24 cm Chronic Hemodialysis Catheter Set (with Cuff 19cm from Tip) --- Catalog No. [REF] 10302803 --- MANUFACTURED IN USA AngioDynamics, Inc., 603 Queensbury Avenue, Queen
Terminated
MSDNone listed
Jan 12, 2012Angiodynamics Worldwide Headquarters
Angiodynamics DuraMax 15.5F x 28 cm Chronic Hemodialysis Catheter Set (with Cuff 23cm from Tip) --- Catalog No. [REF] 10302804 --- MANUFACTURED IN USA AngioDynamics, Inc., 603 Queensbury Avenue, Queen
Terminated
MSDNone listed
Jan 12, 2012Angiodynamics Worldwide Headquarters
Angiodynamics DuraMax 15.5F x 36 cm Chronic Hemodialysis Catheter Set (With Cuff 31cm from Tip) --- Catalog No. [REF] 10302806 --- MANUFACTURED IN USA AngioDynamics, Inc., 603 Queensbury Avenue, Queen
Terminated
MSDNone listed
Jan 12, 2012Angiodynamics Worldwide Headquarters
Angiodynamics DuraMax 15.5F x 40cm Chronic Hemodialysis Catheter Set (with Cuff 35cm from Tip) --- Catalog No. [REF] 10302807 --- MANUFACTURED IN USA AngioDynamics, Inc., 603 Queensbury Avenue, Queens
Terminated
MSDNone listed
Jan 12, 2012Angiodynamics Worldwide Headquarters
Angiodynamics DuraMax 15.5F x 55cm Chronic Hemodialysis Catheter Set (with Cuff 50cm from Tip) --- Catalog No. [REF] 10302809 --- MANUFACTURED IN USA AngioDynamics, Inc., 603 Queensbury Avenue, Queens
Terminated
MSDNone listed
Jan 12, 2012Angiodynamics Worldwide Headquarters
Angiodynamics DuraMax VP Vascpak Catheter Kit 15.5F x 22cm Chronic Hemodialysis VascPak (with Cuff 17cm from Tip) --- Catalog No. [REF] 10302817 --- MANUFACTURED IN USA AngioDynamics, Inc., 603 Queens
Terminated
MSDNone listed
Jan 12, 2012Angiodynamics Worldwide Headquarters
Angiodynamics DuraMax VP Vascpak Catheter Kit 15.5F x 24cm Chronic Hemodialysis VascPak (with Cuff 19cm from Tip) --- Catalog No. [REF] 10302818 --- MANUFACTURED IN USA AngioDynamics, Inc., 603 Queens
Terminated
MSDNone listed
Jan 12, 2012Angiodynamics Worldwide Headquarters
Angiodynamics DuraMax VP Vascpak Catheter Kit 15.5F x 28cm Chronic Hemodialysis VascPak (with Cuff 23cm from Tip) --- Catalog No. [REF] 10302819 --- MANUFACTURED IN USA AngioDynamics, Inc., 603 Queens
Terminated
MSDNone listed
Jan 12, 2012Angiodynamics Worldwide Headquarters
Angiodynamics DuraMax VP Vascpak Catheter Kit 15.5F x 32cm Chronic Hemodialysis VascPak (with Cuff 27cm from Tip) --- Catalog No. [REF] 10302820 --- MANUFACTURED IN USA AngioDynamics, Inc., 603 Queens
Terminated
MSDNone listed
Jan 12, 2012Angiodynamics Worldwide Headquarters
Angiodynamics DuraMax VP Vascpak Catheter Kit 15.5F x 40cm Chronic Hemodialysis VascPak (with Cuff 35cm from Tip) --- Catalog No. [REF] 10302822 --- MANUFACTURED IN USA AngioDynamics, Inc., 603 Queens
Terminated
MSDNone listed
Jan 12, 2012Angiodynamics Worldwide Headquarters
Angiodynamics DuraMax VP Vascpak Catheter Kit 15.5F x 55cm Chronic Hemodialysis VascPak (with Cuff 50cm from Tip) --- Catalog No. [REF] 10302824 --- MANUFACTURED IN USA AngioDynamics, Inc., 603 Queens
Terminated
MSDNone listed
Jan 12, 2012Angiodynamics Worldwide Headquarters
Angiodynamics DuraMax 22 cm STRAIGHT --- 1-15.5F x 22cm DuraMax Hemodialysis Catheter (with Cuff 17cm from Tip), 2- Injection Caps --- Catalog No. [REF] 10302902 --- MANUFACTURED IN USA AngioDynamics,
Terminated
MSDNone listed
Jan 12, 2012Angiodynamics Worldwide Headquarters
Angiodynamics DuraMax 24 cm STRAIGHT --- 1-15.5F x 24cm DuraMax Hemodialysis Catheter (with Cuff 19cm from Tip), 2- Injection Caps --- Catalog No. [REF] 10302903 --- MANUFACTURED IN USA AngioDynamics,
Terminated
MSDNone listed
Jan 12, 2012Angiodynamics Worldwide Headquarters
Angiodynamics DuraMax 55 cm STRAIGHT --- 1-15.5F x 55cm DuraMax Hemodialysis Catheter (with Cuff 50cm from Tip), 2- Injection Caps --- Catalog No. [REF] 10302909 --- MANUFACTURED IN USA AngioDynamics,
Terminated
MSDNone listed
Jan 11, 2012Angiodynamics, Inc.
DURAMAX 15.5 F x 22 cm Chronic Hemodialysis Catheter Set (With Cuff 17 cm from Tip), DuraMax Stacked Tip 22 cm Str. Basic Kit, Catalog No./REF 10302802, STERILE --- AngioDynamics, Inc. 603 Queensbury,
Terminated
MSDNone listed
Jan 11, 2012Angiodynamics, Inc.
DURAMAX 15.5 F x 24 cm Chronic Hemodialysis Catheter Set (With Cuff 19 cm from Tip), DuraMax Stacked Tip 24 cm Str. Basic Kit, Catalog No./REF 10302803, STERILE --- AngioDynamics, Inc. 603 Queensbury
Terminated
MSDNone listed
Jan 11, 2012Angiodynamics, Inc.
DURAMAX 15.5 F x 28 cm Chronic Hemodialysis Catheter Set (With Cuff 23 cm from Tip), DuraMax Stacked Tip 28 cm Str. Basic Kit, Catalog No./REF 10302804, STERILE --- AngioDynamics, Inc. 603 Queensbury
Terminated
MSDNone listed
Jan 11, 2012Angiodynamics, Inc.
DURAMAX 15.5 F x 32 cm Chronic Hemodialysis Catheter Set (With Cuff 27 cm from Tip), DuraMax Stacked Tip 32 cm Str. Basic Kit, Catalog No./REF 10302805, STERILE --- AngioDynamics, Inc. 603 Queensbury
Terminated
MSDNone listed
Jan 11, 2012Angiodynamics, Inc.
DURAMAX 15.5 F x 36 cm Chronic Hemodialysis Catheter Set (With Cuff 31 cm from Tip), DuraMax Stacked Tip 36 cm Str. Basic Kit, Catalog No./REF 10302806, STERILE --- AngioDynamics, Inc. 603 Queensbury,
Terminated
MSDNone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.