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) |
|---|---|---|---|
| Nov 17, 2009 | Spire Biomedical, Inc. 32CM DECATHLON EXCHANGE KIT
Model: DX27SH32-XP
DECATHLON MINI KIT
15.5 Fr polyurethane twin lumen hemodialysis catheter with separated tips, cuff and side holes for chronic hemodialysis and
apheresis Terminated |
MSD | K032061 K040509 +4 |
| Nov 17, 2009 | Spire Biomedical, Inc. 28CM DECATHLON EXCHANGE KIT
Model: DX23SH28-XP
DECATHLON MINI KIT
15.5 Fr polyurethane twin lumen hemodialysis catheter with separated tips, cuff and side holes for chronic hemodialysis and
apheresis Terminated |
MSD | K032061 K040509 +3 |
| Nov 17, 2009 | Spire Biomedical, Inc. 24CM DECATHLON EXCHANGE KIT
Model: DX19SH24-XP
DECATHLON MINI KIT
15.5 Fr polyurethane twin lumen hemodialysis catheter with separated tips, cuff and side holes for chronic hemodialysis and
apheresis Terminated |
MSD | K032061 K040509 +4 |
| Nov 17, 2009 | Spire Biomedical, Inc. 32CM DECATHLON MINI KIT
Model: DM27SH32
DECATHLON MINI KIT
15.5 Fr polyurethane twin lumen hemodialysis catheter with separated tips, cuff and side holes for chronic hemodialysis and apheresis. Kit c Terminated |
MSD | K032061 K040509 +4 |
| Nov 17, 2009 | Spire Biomedical, Inc. 28CM DECATHLON MINI KIT
Model: DM23SH28
DECATHLON MINI KIT
15.5 Fr polyurethane twin lumen hemodialysis catheter with separated tips, cuff and side holes for chronic hemodialysis and
apheresis. Kit co Terminated |
MSD | K032061 K040509 +4 |
| Nov 17, 2009 | Spire Biomedical, Inc. 24CM DECATHLON MINI KIT
Model: DM19SH24
DECATHLON MINI KIT
15.5 Fr polyurethane twin lumen hemodialysis catheter with separated tips, cuff and side holes for chronic hemodialysis and
apheresis. Kit co Terminated |
MSD | K032061 K040509 +4 |
| Nov 17, 2009 | Spire Biomedical, Inc. 32CM DECATHLON FUNNEL TIP CATHETER
Model: DF27SH32-100
DECATHLON FUNNEL TIP - CATHETER ONLY
15.5 Fr polyurethane twin lumen hemodialysis catheter with separated tips, cuff and side holes for chronic Terminated |
MSD | K032061 K040509 +4 |
| Nov 17, 2009 | Spire Biomedical, Inc. 28CM DECATHLON FUNNEL TIP CATHETER
Model: DF23SH28-100
DECATHLON FUNNEL TIP - CATHETER ONLY
15.5 Fr polyurethane twin lumen hemodialysis catheter with separated tips, cuff and side holes for chronic Terminated |
MSD | K032061 K040509 +4 |
| Nov 17, 2009 | Spire Biomedical, Inc. 24CM DECATHLON FUNNEL TIP CATHETER
Model: DF19SH24-100
DECATHLON FUNNEL TIP - CATHETER ONLY
15.5 Fr polyurethane twin lumen hemodialysis catheter with separated tips, cuff and side holes for chronic Terminated |
MSD | K032061 K040509 +4 |
| Nov 17, 2009 | Spire Biomedical, Inc. 55CM DECATHLON FUNNEL TIP STD KIT
Model: DF50SH55
DECATHLON FUNNEL TIP
15.5 Fr polyurethane twin lumen 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. 40CM DECATHLON FUNNEL TIP STD KIT
Model: DF35SH40
DECATHLON FUNNEL TIP
15.5 Fr polyurethane twin lumen 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. 36CM DECATHLON FUNNEL TIP STD KIT
Model: DF31SH36
DECATHLON FUNNEL TIP
15.5 Fr polyurethane twin lumen 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. 32CM DECATHLON FUNNEL TIP STD KIT
Model: DF27SH32
DECATHLON FUNNEL TIP
15.5 Fr polyurethane twin lumen 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 FUNNEL TIP STD KIT
Model: DF23SH28
DECATHLON FUNNEL TIP
15.5 Fr polyurethane twin lumen 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. 24CM DECATHLON FUNNEL TIP STD KIT
Model: DF19SH24
DECATHLON FUNNEL TIP
15.5 Fr polyurethane twin lumen 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. 55CM DECATHLON STD KIT
Models: DE50SH55 and DE50SH55-K
15.5 Fr Polyurethane twin lumen hemodialysis catheter with separated tips, cuff and side holes for chronic hemodialysis and apheresis. Terminated |
MSD | K032061 K040509 +4 |
| Nov 17, 2009 | Spire Biomedical, Inc. 40CM DECATHLON STD KIT
Models: DE35SH40 and DE35SH40-K
15.5 Fr Polyurethane twin lumen hemodialysis catheter with separated tips, cuff and side holes for chronic hemodialysis and apheresis. Terminated |
MSD | K032061 K040509 +4 |
| Nov 17, 2009 | Spire Biomedical, Inc. 36CM DECATHLON STD KIT
Models: DE31SH36 and DE31SH36-K
15.5 Fr Polyurethane twin lumen hemodialysis catheter with separated tips, cuff and side holes for chronic hemodialysis and apheresis. Kit 28cm Terminated |
MSD | K032061 K040509 +4 |
| Nov 17, 2009 | Spire Biomedical, Inc. 32CM DECATHLON STD KIT
Models: DE27SH32 and DE27SH32-K
15.5 Fr Polyurethane twin lumen hemodialysis catheter with separated tips, cuff and side holes for chronic hemodialysis and apheresis. Terminated |
MSD | K032061 K040509 +4 |
| Nov 17, 2009 | Spire Biomedical, Inc. 28CM DECATHLON STD KIT
Models: DE23SH28 and DE23SH28-K
15.5 Fr Polyurethane twin lumen hemodialysis catheter with separated tips, cuff and side holes for chronic hemodialysis and apheresis. Terminated |
MSD | K032061 K040509 +4 |
| Nov 17, 2009 | Spire Biomedical, Inc. 24CM DECATHLON STD KIT
Models: DE19SH24 and DE19SH24-K
15.5 Fr Polyurethane twin lumen hemodialysis catheter with separated tips, cuff and side holes for chronic hemodialysis and apheresis. Terminated |
MSD | K032061 K040509 +4 |
| Nov 10, 2009 | Medical Components, Inc dba MedComp Medcomp, 10F Bioflex Tesio Kit with cutting trocar. Catalog number BFR-6CTT 5 per box.
Hemodialysis catheter insertion kits. Terminated |
MSD | K971925 |
| Sep 24, 2008 | Angiodynamics, Inc. Centros(TM) 15F x 32cm Chronic Hemodialysis Curved Catheter Set (With Cuff 27cm From Tip), Catalog No./REF 10303103. Sterile. Manufactured for AngioDynamics, Inc. MANUFACTURED IN USA. ANGIODYNAMICS, Terminated |
MSD | K070572 |
| Sep 24, 2008 | Angiodynamics, Inc. Centros(TM) 15F x 28cm Chronic Hemodialysis Curved Catheter Set (With Cuff 23cm From Tip), Catalog No./REF 10303102. Sterile. Manufactured for AngioDynamics, Inc. MANUFACTURED IN USA. ANGIODYNAMICS, Terminated |
MSD | K070572 |
| Sep 24, 2008 | Angiodynamics, Inc. Centros(TM) 15F x 24cm Chronic Hemodialysis Curved Catheter Set (With Cuff 19cm From Tip), Catalog No./REF 10303101. Sterile. Manufactured for AngioDynamics, Inc. MANUFACTURED IN USA. ANGIODYNAMICS, Terminated |
MSD | K070572 |
| Sep 17, 2008 | Arrow International Inc ARROW Edge Hemodialysis Catherization Set, Long-Term Access, Catheter Length, Cuff to Tip: 50cm, CSD-15552-I, Intended for single use only, Sterile, Rx only, Arrow International, Inc., 2400 Bernville Terminated |
MSD | K040260 |
| Sep 17, 2008 | Arrow International Inc ARROW Edge Hemodialysis Catherization Set, Long-Term Access, Catheter Length, Cuff to Tip: 31cm, CSD-15362-I, Intended for single use only, Sterile, Rx only, Arrow International, Inc., 2400 Bernville Terminated |
MSD | K040260 |
| Sep 17, 2008 | Arrow International Inc ARROW Edge Hemodialysis Catherization Set, Long-Term Access, Cuff to Tip: 27cm, CSD-15322-I, Intended for single use only, Sterile, Rx only, Arrow International, Inc., 2400 Bernville Road, Reading, PA Terminated |
MSD | K040260 |
| Sep 17, 2008 | Arrow International Inc ARROW Edge Hemodialysis Catherization Set, Long-Term Access, Cuff to Tip: 23cm, CSD-15282-I, Intended for single use only, Sterile, Rx only, Arrow International, Inc., 2400 Bernville Road, Reading, PA Terminated |
MSD | K040260 |
| Sep 17, 2008 | Arrow International Inc ARROW Edge Hemodialysis Catherization Set, Long-Term Access, Cuff to Tip: 19cm, CSD-15242-I, Intended for single use only, Sterile, Rx only, Arrow International, Inc., 2400 Bernville Road, Reading, PA Terminated |
MSD | K040260 |
| Sep 17, 2008 | Arrow International Inc ARROW Edge Hemodialysis Catherization Set, Long-Term Access, Catheter Length, Cuff to Tip: 50cm, CS-15552-I, Intended for single use only, Sterile, Rx only, Arrow International, Inc., 2400 Bernville R Terminated |
MSD | K040260 |
| Sep 17, 2008 | Arrow International Inc ARROW Edge Hemodialysis Catherization Set, Long-Term Access, Catheter Length, Cuff to Tip: 31cm, CS-15362-I, Intended for single use only, Sterile, Rx only, Arrow International, Inc., 2400 Bernville R Terminated |
MSD | K040260 |
| Sep 17, 2008 | Arrow International Inc ARROW Edge Hemodialysis Catherization Set, Long-Term Access, Cuff to Tip: 27cm, CS-15322-I, Intended for single use only, Sterile, Rx only, Arrow International, Inc., 2400 Bernville Road, Reading, PA Terminated |
MSD | K040260 |
| Sep 17, 2008 | Arrow International Inc ARROW Edge Hemodialysis Catherization Set, Long-Term Access, Cuff to Tip: 23cm, CS-15282-I, Intended for single use only, Sterile, Rx only, Arrow International, Inc., 2400 Bernville Road, Reading, PA Terminated |
MSD | K040260 |
| Sep 17, 2008 | Arrow International Inc ARROW Edge Hemodialysis Catherization Set, Long-Term Access, Cuff to Tip: 19cm, CS-15242-I, Intended for single use only, Sterile, Rx only, Arrow International, Inc., 2400 Bernville Road, Reading, PA Terminated |
MSD | K040260 |
| Sep 17, 2008 | Arrow International Inc ARROW Edge Hemodialysis Catherization Set, Long-Term Access, Cuff to Tip: 31cm, ASK-15362-I, Intended for single use only, Sterile, Rx only, Arrow International, Inc., 2400 Bernville Road, Reading, PA Terminated |
MSD | K040260 |
| Sep 17, 2008 | Arrow International Inc ARROW Edge Hemodialysis Catherization Set with Arrow Simplicity", Long-Term Access, Cuff to Tip: 31cm, CS-15362-IM, Intended for single use only, Sterile, Rx only, Arrow International, Inc., 2400 Bern Terminated |
MSD | K040260 |
| Sep 17, 2008 | Arrow International Inc ARROW Edge Hemodialysis Catherization Set with Arrow Simplicity", Long-Term Access, Cuff to Tip: 27cm, CS-15322-IM, Intended for single use only, Sterile, Rx only, Arrow International, Inc., 2400 Bern Terminated |
MSD | K040260 |
| Sep 17, 2008 | Arrow International Inc ARROW Edge Hemodialysis Catherization Set with Arrow Simplicity", Long-Term Access, Cuff to Tip: 23cm, CS-15282-IM, Intended for single use only, Sterile, Rx only, Arrow International, Inc., 2400 Bern Terminated |
MSD | K040260 |
| Sep 17, 2008 | Arrow International Inc ARROW Edge Hemodialysis Catherization Set with Arrow Simplicity", Long-Term Access, Cuff to Tip: 19cm, CS-15242-IM, Intended for single use only, Sterile, Rx only, Arrow International, Inc., 2400 Bern Terminated |
MSD | K040260 |
| Sep 17, 2008 | Arrow International Inc Cannon II Plus, Hemodialysis Catherization Set with Arrow Simplicity", Long-Term Access, Cuff to Tip: 31cm, CS-15362-SPM, Intended for single use only, Sterile, Rx only, Arrow International, Inc., 240 Terminated |
MSD | K040078 |
| Sep 17, 2008 | Arrow International Inc Cannon II Plus, Hemodialysis Catherization Set with Arrow Simplicity", Long-Term Access, Cuff to Tip: 27cm, CS-15322-SPM, Intended for single use only, Sterile, Rx only, Arrow International, Inc., 240 Terminated |
MSD | K040078 |
| Sep 17, 2008 | Arrow International Inc Cannon II Plus, Hemodialysis Catherization Set with Arrow Simplicity", Long-Term Access, Cuff to Tip: 23cm, CS-15282-SPM, Intended for single use only, Sterile, Rx only, Arrow International, Inc., 240 Terminated |
MSD | K040078 |
| Sep 17, 2008 | Arrow International Inc Cannon II Plus, Hemodialysis Catherization Set with Arrow Simplicity", Long-Term Access, Cuff to Tip: 19cm, CS-15242-SPM, Intended for single use only, Sterile, Rx only, Arrow International, Inc., 240 Terminated |
MSD | K040078 |
| Sep 17, 2008 | Arrow International Inc Cannon II Plus, Hemodialysis Catherization Set, Long-Term Access. Catheter Length, Cuff to Tip: 50cm, CSD-15552-SP, Intended for single use only, Sterile, Rx only, Arrow International, Inc., 2400 Bern Terminated |
MSD | K040078 |
| Sep 17, 2008 | Arrow International Inc Cannon II Plus, Hemodialysis Catherization Set, Long-Term Access. Catheter Length, Cuff to Tip: 31cm, CSD-15362-SP, Intended for single use only, Sterile, Rx only, Arrow International, Inc., 2400 Bern Terminated |
MSD | K040078 |
| Sep 17, 2008 | Arrow International Inc Cannon II Plus, Hemodialysis Catherization Set, Long-Term Access. Catheter Length, Cuff to Tip: 27cm, CSD-15322-SP, Intended for single use only, Sterile, Rx only, Arrow International, Inc., 2400 Bern Terminated |
MSD | K040078 |
| Sep 17, 2008 | Arrow International Inc Cannon II Plus, Hemodialysis Catherization Set, Long-Term Access. Catheter Length, Cuff to Tip: 23cm, CSD-15282-SP, Intended for single use only, Sterile, Rx only, Arrow International, Inc., 2400 Bern Terminated |
MSD | K040078 |
| Sep 17, 2008 | Arrow International Inc Cannon II Plus, Hemodialysis Catherization Set, Long-Term Access. Catheter Length, Cuff to Tip: 19cm, CSD-15242-SP, Intended for single use only, Sterile, Rx only, Arrow International, Inc., 2400 Bern Terminated |
MSD | K040078 |
| Sep 17, 2008 | Arrow International Inc Cannon II Plus, Long-Term Access. Catheter Length, Cuff to Tip: 50cm, CS-15552-VSP, Intended for single use only, Sterile, Rx only, Arrow International, Inc., 2400 Bernville Road, Reading, PA 19605, U Terminated |
MSD | K040078 |
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