Atlas FDA

DURAMAX CHRONIC HEMODIALYSIS CATHETER AND PROCEDURE KIT

FDA 510(k) clearance K101843 · decided 2010-10-20

Clearance details

K-number
K101843
Device name
DURAMAX CHRONIC HEMODIALYSIS CATHETER AND PROCEDURE KIT
Applicant
AngioDynamics, Inc.
Decision
Unknown
Date received
2010-07-01
Decision date
2010-10-20
Days to decision
111 days
Clearance type
Traditional
Product code
MSD
Device class
2
Regulation number
876.5540
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Latham, NY, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
DuraMax Chronic Hemodialysis Catheter, REF: H787103028015/A, H787103028025/A, H78710302803 recall (Z-1578-2026)Merit Medical Systems, Inc.2026-03-26
DURAMAX STACKED TIP 24CM STR. BASIC KIT, 1-UP PG Product Number: H787103028031 recall (Z-1766-2024)Angiodynamics, Inc.2024-05-03
DURAMAX STACKED TIP 24CM STR. BASIC KIT, 5-UP PG- Indicated for use in attaining Long-Term recall (Z-1767-2024)Angiodynamics, Inc.2024-05-03
DURAMAX STACKED TIP 28CM STR. BASIC KIT, 1-UP PG- Indicated for use in attaining Long-Term recall (Z-1768-2024)Angiodynamics, Inc.2024-05-03
DURAMAX STACKED TIP 28CM STR. BASIC KIT, 5-UP PG- Indicated for use in attaining Long-Term recall (Z-1769-2024)Angiodynamics, Inc.2024-05-03
DURAMAX STACKED TIP 32CM STR. BASIC KIT, 5-UP PG- Indicated for use in attaining Long-Term recall (Z-1770-2024)Angiodynamics, Inc.2024-05-03
DURAMAX STACKED TIP 28 CM STRAIGHT VASC-PAK, 1-UP PG- Indicated for use in attaining Long- recall (Z-1771-2024)Angiodynamics, Inc.2024-05-03
DURAMAX STACKED TIP 28 CM STRAIGHT VASC-PAK, 5-UP PG- Indicated for use in attaining Long- recall (Z-1772-2024)Angiodynamics, Inc.2024-05-03
DURAMAX STACKED TIP 32 CM STRAIGHT VASC-PAK, 1-UP PG- Indicated for use in attaining Long- recall (Z-1773-2024)Angiodynamics, Inc.2024-05-03
Angiodynamics DuraMax 15.5F x 32 cm Chronic Hemodialysis Catheter Set (with Cuff 27cm from recall (Z-0718-2012)Angiodynamics Worldwide Headquarters2012-01-12
Angiodynamics DuraMax 15.5F x 22 cm Chronic Hemodialysis Catheter Set (with Cuff 17cm from recall (Z-0719-2012)Angiodynamics Worldwide Headquarters2012-01-12
Angiodynamics DuraMax 15.5F x 24 cm Chronic Hemodialysis Catheter Set (with Cuff 19cm from recall (Z-0720-2012)Angiodynamics Worldwide Headquarters2012-01-12
Angiodynamics DuraMax 15.5F x 28 cm Chronic Hemodialysis Catheter Set (with Cuff 23cm from recall (Z-0721-2012)Angiodynamics Worldwide Headquarters2012-01-12
Angiodynamics DuraMax 15.5F x 36 cm Chronic Hemodialysis Catheter Set (With Cuff 31cm from recall (Z-0722-2012)Angiodynamics Worldwide Headquarters2012-01-12
Angiodynamics DuraMax 15.5F x 40cm Chronic Hemodialysis Catheter Set (with Cuff 35cm from recall (Z-0723-2012)Angiodynamics Worldwide Headquarters2012-01-12
Angiodynamics DuraMax 15.5F x 55cm Chronic Hemodialysis Catheter Set (with Cuff 50cm from recall (Z-0724-2012)Angiodynamics Worldwide Headquarters2012-01-12
Angiodynamics DuraMax VP Vascpak Catheter Kit 15.5F x 22cm Chronic Hemodialysis VascPak (w recall (Z-0725-2012)Angiodynamics Worldwide Headquarters2012-01-12
Angiodynamics DuraMax VP Vascpak Catheter Kit 15.5F x 24cm Chronic Hemodialysis VascPak (w recall (Z-0726-2012)Angiodynamics Worldwide Headquarters2012-01-12
Angiodynamics DuraMax VP Vascpak Catheter Kit 15.5F x 28cm Chronic Hemodialysis VascPak (w recall (Z-0727-2012)Angiodynamics Worldwide Headquarters2012-01-12
Angiodynamics DuraMax VP Vascpak Catheter Kit 15.5F x 32cm Chronic Hemodialysis VascPak (w recall (Z-0728-2012)Angiodynamics Worldwide Headquarters2012-01-12
Angiodynamics DuraMax VP Vascpak Catheter Kit 15.5F x 40cm Chronic Hemodialysis VascPak (w recall (Z-0729-2012)Angiodynamics Worldwide Headquarters2012-01-12
Angiodynamics DuraMax VP Vascpak Catheter Kit 15.5F x 55cm Chronic Hemodialysis VascPak (w recall (Z-0730-2012)Angiodynamics Worldwide Headquarters2012-01-12
Angiodynamics DuraMax 22 cm STRAIGHT --- 1-15.5F x 22cm DuraMax Hemodialysis Catheter (wit recall (Z-0731-2012)Angiodynamics Worldwide Headquarters2012-01-12
Angiodynamics DuraMax 24 cm STRAIGHT --- 1-15.5F x 24cm DuraMax Hemodialysis Catheter (wit recall (Z-0732-2012)Angiodynamics Worldwide Headquarters2012-01-12
Angiodynamics DuraMax 55 cm STRAIGHT --- 1-15.5F x 55cm DuraMax Hemodialysis Catheter (wit recall (Z-0733-2012)Angiodynamics Worldwide Headquarters2012-01-12
DURAMAX 15.5 F x 22 cm Chronic Hemodialysis Catheter Set (With Cuff 17 cm from Tip), DuraM recall (Z-0586-2012)Angiodynamics, Inc.2012-01-11
DURAMAX 15.5 F x 24 cm Chronic Hemodialysis Catheter Set (With Cuff 19 cm from Tip), DuraM recall (Z-0587-2012)Angiodynamics, Inc.2012-01-11
DURAMAX 15.5 F x 28 cm Chronic Hemodialysis Catheter Set (With Cuff 23 cm from Tip), DuraM recall (Z-0588-2012)Angiodynamics, Inc.2012-01-11
DURAMAX 15.5 F x 32 cm Chronic Hemodialysis Catheter Set (With Cuff 27 cm from Tip), DuraM recall (Z-0589-2012)Angiodynamics, Inc.2012-01-11
DURAMAX 15.5 F x 36 cm Chronic Hemodialysis Catheter Set (With Cuff 31 cm from Tip), DuraM recall (Z-0590-2012)Angiodynamics, Inc.2012-01-11