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)
Top companies in MSD
| Company | 510(k)s | Recalls |
|---|---|---|
| Covidien | 3 | 71 |
| Spire Biomedical, Inc. | 13 | 48 |
| Arrow International, Inc. | 4 | 50 |
| AngioDynamics, Inc. | 4 | 34 |
| Bard Peripheral Vascular, Inc. | 1 | 30 |
| Angiodynamics Worldwide Headquarters | 0 | 16 |
| Medcomp | 13 | 0 |
| C. R. Bard | 12 | 0 |
| Kendall | 9 | 0 |
| Marvao Medical Devices, Ltd. | 7 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 1, 2015 | Covidien LLC Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm
Item Code: 8888145049CP Terminated |
MSD | K062671 K112477 +1 |
| Jul 1, 2015 | Covidien LLC Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm
Item Code: 8888145049P Terminated |
MSD | K062671 K112477 +1 |
| Jul 1, 2015 | Covidien LLC Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 23cm
Item Code: 8888145048CP Terminated |
MSD | K062671 K112477 +1 |
| Jul 1, 2015 | Covidien LLC Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 23cm
Item Code: 8888145048P Terminated |
MSD | K062671 K112477 +1 |
| Jul 1, 2015 | Covidien LLC Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 19cm
Item Code: 8888145057CP Terminated |
MSD | K062671 K112477 +1 |
| Jul 1, 2015 | Covidien LLC Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm
Item Code: 8888145050C Terminated |
MSD | K062671 K112477 +1 |
| Jul 1, 2015 | Covidien LLC Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm
Item Code: 8888145050C Terminated |
MSD | K062671 K112477 |
| Jul 1, 2015 | Covidien LLC Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm
Item Code: 8888145050 Terminated |
MSD | K062671 K112477 |
| Jul 1, 2015 | Covidien LLC Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm
Item Code:8888145049C Terminated |
MSD | K062671 K112477 |
| Jul 1, 2015 | Covidien LLC Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm
Item Code: 8888145049 Terminated |
MSD | K062671 K112477 |
| Jul 1, 2015 | Covidien LLC Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 23cm
Item Code: 8888145048C Terminated |
MSD | K062671 K112477 |
| Jul 1, 2015 | Covidien LLC Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 19cm
Item Code: 8888145048 Terminated |
MSD | K062671 K112477 |
| Jul 1, 2015 | Covidien LLC Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 19cm
Item Code: 8888145057C Terminated |
MSD | K062671 K112477 |
| Jul 1, 2015 | Covidien LLC Palindrome Precision SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 33cm
Item Code: 8888133508P Terminated |
MSD | K062671 K112477 |
| Jul 1, 2015 | Covidien LLC Palindrome Precision SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 33cm
Item Code: 8888133508P Terminated |
MSD | K060972 K112477 +1 |
| Jul 1, 2015 | Covidien LLC Palindrome Precision SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 28cm
Item Code: 8888128458P Terminated |
MSD | K060972 K112477 +1 |
| Jul 1, 2015 | Covidien LLC Palindrome Precision SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 23cm
Item Code: 8888123408P Terminated |
MSD | K060972 K112477 +1 |
| Jul 1, 2015 | Covidien LLC Palindrome Precision SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 19cm
Item Code: 8888119368P Terminated |
MSD | K060972 K112477 +1 |
| Jul 1, 2015 | Covidien LLC Palindrome Precision SI Chronic Catheter Kit 14.5 Fr x 55cm
Item Code: 8888145066CP Terminated |
MSD | K060972 K112477 |
| Jul 1, 2015 | Covidien LLC Palindrome Precision SI Chronic Catheter Kit 14.5 Fr x 55cm
Item Code: 8888145066CP Terminated |
MSD | K060972 K112477 +1 |
| Jul 1, 2015 | Covidien LLC Palindrome Precision SI Chronic Catheter Kit 14.5 Fr x 55cm
Item Code: 8888145066P Terminated |
MSD | K060972 K112477 +1 |
| Jul 1, 2015 | Covidien LLC Palindrome Precision SI Chronic Catheter Kit 14.5 Fr x 44cm
Item Code: 8888146144CP Terminated |
MSD | K060972 K112477 +1 |
| Jul 1, 2015 | Covidien LLC Palindrome Precision SI Chronic Catheter Kit 14.5 Fr x 44cm
Item Code: 8888146144P Terminated |
MSD | K060972 K112477 +1 |
| Jul 1, 2015 | Covidien LLC Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cmItem Code: 8888145065CP Terminated |
MSD | K060972 K112477 +1 |
| Jul 1, 2015 | Covidien LLC Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm
Item Code: 8888145065P Terminated |
MSD | K060972 K112477 +1 |
| Jul 1, 2015 | Covidien LLC Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm
Item Code: 8888145064CP Terminated |
MSD | K060972 K112477 +1 |
| Jul 1, 2015 | Covidien LLC Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm
Item Code: 8888145064P Terminated |
MSD | K060972 K112477 +1 |
| Jul 1, 2015 | Covidien LLC Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 23cm
Item Code: 8888145063CP Terminated |
MSD | K060972 K112477 +1 |
| Jul 1, 2015 | Covidien LLC Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 23cm
Item Code: 8888145063P Terminated |
MSD | K060972 K112477 +1 |
| Jul 1, 2015 | Covidien LLC Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 19cm
Item Code: 8888145062CP Terminated |
MSD | K060972 K112477 +1 |
| Jul 1, 2015 | Covidien LLC Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 19cm
Item Code: 8888145062P Terminated |
MSD | K060972 K112477 +1 |
| Mar 30, 2015 | Medical Components, Inc dba MedComp Medcomp Duo-Flow 400XL Catheter, Hemo-Flow Catheter, SLX Catheter, Triple Lumen Infusion Catheter, CT rated PICC, Split Cath III, PC Split Cath III;
AngioDynamics product- Dura-Flow Catheter, Schon Terminated |
MSD | K030502 K111651 +1 |
| Jan 22, 2015 | Arrow International Inc The Arrow Edge Hemodialysis Catheterization Set Long-Term Access and NextStep Antegrade Hemodialysis Catheterization Set, Long-Term Access, part numbers: AC-15192-SFX, AC-15232-SFX, AC-15272-SFX, AC-1 Terminated |
MSD | K111117 K111900 |
| Sep 24, 2014 | Argon Medical Devices, Inc UltraStream Peel Away Kit; Model Numbers 32401524 (24 cm), 32401528 (28cm), 32401532 (32 cm), and 32401536 (36 cm) and 32402540 (40 cm)
The Rex Medical UltraStream Chronic Hemodialysis Catheter is a Terminated |
MSD | K023847 K102043 |
| Sep 24, 2014 | Argon Medical Devices, Inc UltraStream Exchange Kit Model Numbers 32001524 (24 cm), 32001528 (28cm), 32001532 (32 cm), and 32001536 (36 cm) and 32002540 (40 cm). The Rex Medical UltraStream Chronic Hemodialysis Catheter is a c Terminated |
MSD | K023847 K102043 |
| Sep 24, 2014 | Argon Medical Devices, Inc UltraStream Chronic Hemodialysis Catheter Standard Kit; Model Number 32101524 (24 cm), 32101528 (28cm), 32101532 (32 cm), and 32101536 (36 cm) and 32102540 (40 cm). The Rex Medical UltraStream Chronic Terminated |
MSD | K023847 K102043 |
| Sep 4, 2014 | Medical Components, Inc dba MedComp Split Cath III Trays, 16F x 28CM
Product Usage:
The Split Cath III is indicated for use in attaining long term vascular access for hemodialysis and apheresis in adult patients. Terminated |
MSD | K121848 |
| Aug 27, 2012 | Bard Access Systems 16 Fr HemoStar XK Long-Term Hemodialysis Catheter, implanted Standard kit containing an AirGuard introducer. The device is used for patients requiring hemodialysis.
The HemoStar XK catheter is made 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 | K101843 |
| 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 | K101843 |
| 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 | K101843 |
| 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 | K101843 |
| 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 | K101843 |
| 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 | K101843 |
| 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 | K101843 |
| 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 | K101843 |
| 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 | K101843 |
| 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 | K101843 |
| 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 | K101843 |
| 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 | K101843 |
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