510(k) K101843 ยท MSD Catheter, Hemodialysis, Implanted
DURAMAX CHRONIC HEMODIALYSIS CATHETER AND PROCEDURE KIT
| Applicant | AngioDynamics, Inc., Latham NY, US |
| Decision | Unknown, Oct 20, 2010 |
| Received | Jul 1, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K101843
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 26, 2026 | Merit 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 |
MSD | None listed |
| May 3, 2024 | Angiodynamics, Inc. DURAMAX STACKED TIP 24CM STR. BASIC KIT, 1-UP PG
Product Number: H787103028031 Open, Classified |
MSD | None listed |
| May 3, 2024 | Angiodynamics, 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 |
MSD | None listed |
| May 3, 2024 | Angiodynamics, 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 |
MSD | None listed |
| May 3, 2024 | Angiodynamics, 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 |
MSD | None listed |
| May 3, 2024 | Angiodynamics, 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 |
MSD | None listed |
| May 3, 2024 | Angiodynamics, 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 |
MSD | None listed |
| May 3, 2024 | Angiodynamics, 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 |
MSD | None listed |
| May 3, 2024 | Angiodynamics, 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 |
MSD | None listed |
| Jan 12, 2012 | Angiodynamics 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 |
MSD | None listed |
| Jan 12, 2012 | Angiodynamics 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 |
MSD | None listed |
| Jan 12, 2012 | Angiodynamics 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 |
MSD | None listed |
| Jan 12, 2012 | Angiodynamics 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 |
MSD | None listed |
| Jan 12, 2012 | Angiodynamics 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 |
MSD | None listed |
| Jan 12, 2012 | Angiodynamics 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 |
MSD | None listed |
| Jan 12, 2012 | Angiodynamics 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 |
MSD | None listed |
| Jan 12, 2012 | Angiodynamics 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 |
MSD | None listed |
| Jan 12, 2012 | Angiodynamics 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 |
MSD | None listed |
| Jan 12, 2012 | Angiodynamics 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 |
MSD | None listed |
| Jan 12, 2012 | Angiodynamics 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 |
MSD | None listed |
| Jan 12, 2012 | Angiodynamics 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 |
MSD | None listed |
| Jan 12, 2012 | Angiodynamics 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 |
MSD | None listed |
| Jan 12, 2012 | Angiodynamics 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 |
MSD | None listed |
| Jan 12, 2012 | Angiodynamics 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 |
MSD | None listed |
| Jan 12, 2012 | Angiodynamics 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 |
MSD | None listed |
| Jan 11, 2012 | Angiodynamics, 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 |
MSD | None listed |
| Jan 11, 2012 | Angiodynamics, 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 |
MSD | None listed |
| Jan 11, 2012 | Angiodynamics, 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 |
MSD | None listed |
| Jan 11, 2012 | Angiodynamics, 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 |
MSD | None listed |
| Jan 11, 2012 | Angiodynamics, 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 |
MSD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.