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) |
|---|---|---|---|
| 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 | K101843 |
| 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 | K101843 |
| 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 | K101843 |
| 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 | K101843 |
| 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 | K080400 K101843 |
| 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 | K080400 K101843 |
| 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 | K080400 K101843 |
| 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 | K080400 K101843 |
| 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 | K080400 K101843 |
| Jul 30, 2011 | Arrow International Inc Arrow NextStep Antegrade Chronic Hemodialysis Catheter.
Product is used for attaining long-term vascular access for hemodialysis and apheresis. Terminated |
MSD | K102238 |
| Jun 28, 2011 | Medical Components, Inc dba MedComp THD155428- 15.5F X 28cm Titan HD(TM) Catheter Kit
Product Usage: Hemodialysis catheter insertion kit Terminated |
MSD | K030502 |
| Jun 6, 2011 | R4 Vascular Inc DuraspanTM Dialysis Catheters, Ultra and Long Term, 15.5 Fr, Sterile EO, Manufactured for r4 Vascular, Inc . 7550 Meridan Circle North, Suite 150, Maple Grove, MN 55369.
Description Terminated |
MSD | K091506 K100169 |
| Jun 4, 2010 | Angiodynamics, Inc. DURAMAX (TM) Hemodialysis Catheters, Stack Tip 36 cm Pre-Curve Basic Kit, Catalog Number/REF 10302815, 510 (k) 080400, Sterile --- Manufactured in USA by AngioDynamics, Inc. 603 Queensbury Avenue, Qu Terminated |
MSD | None listed |
| Jun 4, 2010 | Angiodynamics, Inc. DURAMAX (TM) Hemodialysis Catheters, Stack Tip 32 cm Pre-Curve Basic Kit, Catalog Number/REF 10302814, 510 (k) 080400, Sterile --- Manufactured in USA by AngioDynamics, Inc. 603 Queensbury Avenue, Qu Terminated |
MSD | None listed |
| Jun 4, 2010 | Angiodynamics, Inc. DURAMAX (TM) Hemodialysis Catheters, Stack Tip 28 cm Pre-Curve Basic Kit, Catalog Number/REF 10302813, 510 (k) 080400, Sterile --- Manufactured in USA by AngioDynamics, Inc. 603 Queensbury Avenue, Qu Terminated |
MSD | None listed |
| Jun 4, 2010 | Angiodynamics, Inc. DURAMAX (TM) Hemodialysis Catheters, Stack Tip 24 cm Pre-Curve Basic Kit, Catalog Number/REF 10302812, 510 (k) 080400, Sterile --- Manufactured in USA by AngioDynamics, Inc. 603 Queensbury Avenue, Qu Terminated |
MSD | None listed |
| Jun 4, 2010 | Angiodynamics, Inc. DURAMAX (TM) Hemodialysis Catheters, Stacked Tip 55 cm Straight Basic Kit, Catalog Number/REF 10302809, 510 (k) 080400, Sterile --- Manufactured in USA by AngioDynamics, Inc. 603 Queensbury Avenue, Q Terminated |
MSD | None listed |
| Jun 4, 2010 | Angiodynamics, Inc. DURAMAX (TM) Hemodialysis Catheters, Stacked Tip 40 cm Straight Basic Kit, Catalog Number/REF 10302807, 510 (k) 080400, Sterile --- Manufactured in USA by AngioDynamics, Inc. 603 Queensbury Avenue, Q Terminated |
MSD | None listed |
| Jun 4, 2010 | Angiodynamics, Inc. DURAMAX (TM) Hemodialysis Catheters, Stacked Tip 36 cm Straight Basic Kit, Catalog Number/REF 10302806, 510 (k) 080400, Sterile --- Manufactured in USA by AngioDynamics, Inc. 603 Queensbury Avenue, Q Terminated |
MSD | None listed |
| Jun 4, 2010 | Angiodynamics, Inc. DURAMAX (TM) Hemodialysis Catheters, Stacked Tip 32 cm Straight Basic Kit, Catalog Number/REF 10302805, 510 (k) 080400, Sterile --- Manufactured in USA by AngioDynamics, Inc. 603 Queensbury Avenue, Q Terminated |
MSD | None listed |
| Jun 4, 2010 | Angiodynamics, Inc. DURAMAX (TM) Hemodialysis Catheters, Stacked Tip 28 cm Straight Basic Kit, Catalog Number/REF 10302804, 510 (k) 080400, Sterile --- Manufactured in USA by AngioDynamics, Inc. 603 Queensbury Avenue, Q Terminated |
MSD | None listed |
| Jun 4, 2010 | Angiodynamics, Inc. DURAMAX (TM) Hemodialysis Catheters, Stacked Tip 24 cm Straight Basic Kit, Catalog Number/REF 10302803, 510 (k) 080400, Sterile --- Manufactured in USA by AngioDynamics, Inc. 603 Queensbury Avenue, Q Terminated |
MSD | None listed |
| Jun 4, 2010 | Angiodynamics, Inc. DURAMAX (TM) Hemodialysis Catheters, Stacked Tip 22 cm Straight Basic Kit, Catalog Number/REF 10302802, 510 (k) 080400, Sterile --- Manufactured in USA by AngioDynamics, Inc. 603 Queensbury Avenue, Q Terminated |
MSD | None listed |
| Nov 17, 2009 | Spire Biomedical, Inc. 55CM ALTA LR GOLD STD KIT
Model: ALC50SH55
ALTA GOLD
15.5 Fr polyurethane twin lumen fixed tip heparin coated hemodialysis catheter, cuff and side holes for chronic hemodialysis and
apheresis. Kit co Terminated |
MSD | K032061 K040509 +4 |
| Nov 17, 2009 | Spire Biomedical, Inc. 40CM ALTA LR GOLD STD KIT
Model: ALC35SH40
ALTA GOLD
15.5 Fr polyurethane twin lumen fixed tip heparin coated hemodialysis catheter, cuff and side holes for chronic hemodialysis and
apheresis. Kit co Terminated |
MSD | K032061 K040509 +4 |
| Nov 17, 2009 | Spire Biomedical, Inc. 36CM ALTA LR GOLD STD KIT
Model: ALC31SH36
ALTA GOLD
15.5 Fr polyurethane twin lumen fixed tip heparin coated hemodialysis catheter, cuff and side holes for chronic hemodialysis and
apheresis. Kit co Terminated |
MSD | K032061 K040509 +4 |
| Nov 17, 2009 | Spire Biomedical, Inc. 32CM ALTA LR GOLD STD KIT
Model: ALC27SH32
ALTA GOLD
15.5 Fr polyurethane twin lumen fixed tip heparin coated hemodialysis catheter, cuff and side holes for chronic hemodialysis and
apheresis. Kit co Terminated |
MSD | K032061 K040509 +4 |
| Nov 17, 2009 | Spire Biomedical, Inc. 28CM ALTA LR GOLD STD KIT
Model: ALC23SH28
ALTA GOLD
15.5 Fr polyurethane twin lumen fixed tip heparin coated hemodialysis catheter, cuff and side holes for chronic hemodialysis and
apheresis. Kit con Terminated |
MSD | K032061 K040509 +4 |
| Nov 17, 2009 | Spire Biomedical, Inc. 24CM ALTA LR GOLD STD KIT
Model: ALC19SH24
ALTA GOLD
15.5 Fr polyurethane twin lumen fixed tip heparin coated hemodialysis catheter, cuff and side holes for chronic hemodialysis and
apheresis. Kit co Terminated |
MSD | K032061 K040509 +4 |
| Nov 17, 2009 | Spire Biomedical, Inc. 32CM ALTA EXCHANGE
Model: AL27SH32 XP
ALTA EXCHANGE KIT
15.5 Fr polyurethane twin lumen fixed tip hemodialysis catheter, cuff and side holes for chronic hemodialysis and apheresis. Latex free Terminated |
MSD | K032061 K040509 +4 |
| Nov 17, 2009 | Spire Biomedical, Inc. 28CM ALTA EXCHANGE KIT
Model: AL23SH28 XP
ALTA EXCHANGE KIT
15.5 Fr polyurethane twin lumen fixed tip hemodialysis catheter, cuff and side holes for chronic hemodialysis and apheresis. Latex
free. Terminated |
MSD | K032061 K040509 +4 |
| Nov 17, 2009 | Spire Biomedical, Inc. 24CM ALTA EXCHANGE KIT
Model: AL19SH24-XP
ALTA EXCHANGE KIT
15.5 Fr polyurethane twin lumen fixed tip hemodialysis catheter, cuff and side holes for chronic hemodialysis and apheresis. Latex free Terminated |
MSD | K032061 K040509 +4 |
| Nov 17, 2009 | Spire Biomedical, Inc. 36CM ALTA LR STANDARD KIT
Model: AL31NH36
ALTA CATHETER WITH NO SIDE HOLES
15.5 Fr polyurethane twin lumen fixed tip hemodialysis catheter, cuff, and no side holes for chronic hemodialysis and apheres Terminated |
MSD | K032061 K040509 +4 |
| Nov 17, 2009 | Spire Biomedical, Inc. 32CM ALTA LR STANDARD KIT
Model: AL27NH32
ALTA CATHETER WITH NO SIDE HOLES
15.5 Fr polyurethane twin lumen fixed tip hemodialysis catheter, cuff, and no side holes for chronic hemodialysis and aphere Terminated |
MSD | K032061 K040509 +4 |
| Nov 17, 2009 | Spire Biomedical, Inc. 28CM ALTA LR STANDARD KIT
Model: AL23NH28
ALTA CATHETER WITH NO SIDE HOLES
15.5 Fr polyurethane twin lumen fixed tip hemodialysis catheter, cuff, and no side holes for chronic hemodialysis and aphere Terminated |
MSD | K032061 K040509 +4 |
| Nov 17, 2009 | Spire Biomedical, Inc. 24CM ALTA LR STANDARD KIT
Model: AL19NH24
ALTA CATHETER WITH NO SIDE HOLES
15.5 Fr polyurethane twin lumen fixed tip hemodialysis catheter, cuff, and no side holes for chronic hemodialysis and aphere Terminated |
MSD | K032061 K040509 +4 |
| Nov 17, 2009 | Spire Biomedical, Inc. 40CM ALTA LR STANDARD KIT
Model: AL35SH40
ALTA CATHETER WITH SIDE HOLES
15.5 Fr polyurethane twin lumen fixed tip hemodialysis catheter, cuff and side holes for chronic hemodialysis and apheresis. Ki Terminated |
MSD | K032061 K040509 +4 |
| Nov 17, 2009 | Spire Biomedical, Inc. 36CM ALTA LR STANDARD KIT
Model: AL31SH36
ALTA CATHETER WITH SIDE HOLES
15.5 Fr polyurethane twin lumen fixed tip hemodialysis catheter, cuff and side holes for chronic hemodialysis and apheresis. Ki Terminated |
MSD | K032061 K040509 +4 |
| Nov 17, 2009 | Spire Biomedical, Inc. 32CM ALTA LR STANDARD KIT
Model: AL27SH32
ALTA CATHETER WITH SIDE HOLES
15.5 Fr polyurethane twin lumen fixed tip hemodialysis catheter, cuff and side holes for chronic hemodialysis and apheresis. Ki Terminated |
MSD | K032061 K040509 +4 |
| Nov 17, 2009 | Spire Biomedical, Inc. 28CM ALTA LR STANDARD KIT High Flow Recirculation
Model: AL23SH28
ALTA CATHETER WITH SIDE HOLES
15.5 Fr polyurethane twin lumen fixed tip hemodialysis catheter, cuff and side holes for chronic hemod Terminated |
MSD | K032061 K040509 +4 |
| Nov 17, 2009 | Spire Biomedical, Inc. 24CM ALTA LR STANDARD KIT High Flow Recirculation Catheter
Model: AL19SH24
ALTA CATHETER WITH SIDE HOLES
15.5 Fr polyurethane twin lumen fixed tip hemodialysis catheter, cuff and side holes for chron Terminated |
MSD | K032061 K040509 +4 |
| Nov 17, 2009 | Spire Biomedical, Inc. 32CM DECATHLON GOLD FUNNEL TIP STD KIT
Model: DFC27SH32
15.5 Fr polyurethane twin lumen Heparin coated hemodialysis catheter with separated funnel tips, cuff and side holes for chronic
hemodialysis a Terminated |
MSD | K032061 K040509 +4 |
| Nov 17, 2009 | Spire Biomedical, Inc. 28CM DECATHLON GOLD FUNNEL TIP STD KIT
Models: DFC23SH28 and DFC23SH28-K
DECATHLON GOLD FUNNEL TIP
15.5 Fr polyurethane twin lumen Heparin coated hemodialysis catheter with separated funnel tips, cuf Terminated |
MSD | K032061 K040509 +4 |
| Nov 17, 2009 | Spire Biomedical, Inc. 24CM DECATHLON GOLD FUNNEL TIP STD KIT
Models: DFC19SH24 and DFC19SH24-K
DECATHLON GOLD FUNNEL TIP
15.5 Fr polyurethane twin lumen Heparin coated hemodialysis catheter with separated funnel tips, cu Terminated |
MSD | K032061 K040509 +4 |
| Nov 17, 2009 | Spire Biomedical, Inc. 55CM DECATHLON GOLD STD KIT
Models: DEC50SH55 and DEC50SH55-K
DECATHLON GOLD
15.5 Fr polyurethane twin lumen Heparin coated hemodialysis catheter with separated tips, cuff and side holes for chronic
Terminated |
MSD | K032061 K040509 +4 |
| Nov 17, 2009 | Spire Biomedical, Inc. 40CM DECATHLON GOLD STD KIT
Models: DEC35SH40 and DEC35SH40-K
DECATHLON GOLD
15.5 Fr polyurethane twin lumen Heparin coated hemodialysis catheter with separated tips, cuff and side holes for chronic
Terminated |
MSD | K032061 K040509 +4 |
| Nov 17, 2009 | Spire Biomedical, Inc. 36CM DECATHLON GOLD STD KIT
Models: DEC31SH36 and DEC31SH36-K
DECATHLON GOLD
15.5 Fr polyurethane twin lumen Heparin coated hemodialysis catheter with separated tips, cuff and side holes for chronic
h Terminated |
MSD | K032061 K040509 +4 |
| Nov 17, 2009 | Spire Biomedical, Inc. 32CM DECATHLON GOLD STD KIT
Models: DEC27SH32 and DEC27SH32-K
DECATHLON GOLD
15.5 Fr polyurethane twin lumen Heparin coated hemodialysis catheter with separated tips, cuff and side holes for chronic
Terminated |
MSD | K032061 K040509 +4 |
| Nov 17, 2009 | Spire Biomedical, Inc. 28CM DECATHLON GOLD STD KIT
Models: DEC23SH28 and DEC23SH28-K Terminated |
MSD | K032061 K040509 +4 |
| Nov 17, 2009 | Spire Biomedical, Inc. 24CM DECATHLON GOLD STD KIT
Models: DEC19SH24 and DEC19SH24-K
DECATHLON GOLD
15.5 Fr polyurethane twin lumen Heparin coated hemodialysis catheter with separated tips, cuff and side holes for chronic Terminated |
MSD | K032061 K040509 +4 |
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