ClearanceBrief
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)
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Top companies in MSD

Company510(k)sRecalls
Covidien371
Spire Biomedical, Inc.1348
Arrow International, Inc.450
AngioDynamics, Inc.434
Bard Peripheral Vascular, Inc.130
Angiodynamics Worldwide Headquarters016
Medcomp130
C. R. Bard120
Kendall90
Marvao Medical Devices, Ltd.71
DateFirm and productCodeLinked 510(k)
May 28, 2021Covidien, LP
Palindrome RT Repair Kit 15 FR TAL 23cm, Sterile, Item Code 8888541123
Open, Classified		 MSDK111817
May 28, 2021Covidien, LP
Palindrome RT Repair Kit 15 FR TAL 19cm, Sterile, Item Code 8888541119
Open, Classified		 MSDK111817
May 28, 2021Covidien, LP
Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 55cm, Item Code 8888541055
Open, Classified		 MSDK111817
May 28, 2021Covidien, LP
Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 44cm, Item Code 8888541044
Open, Classified		 MSDK111817
May 28, 2021Covidien, LP
Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 33cm, Item Code 8888541033
Open, Classified		 MSDK111817
May 28, 2021Covidien, LP
Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 28 cm, Item Code 8888541028
Open, Classified		 MSDK111817
May 28, 2021Covidien, LP
Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 23 cm, Item Code 8888541023
Open, Classified		 MSDK111817
May 28, 2021Covidien, LP
Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 19 cm, Item Code 8888541019
Open, Classified		 MSDK111817
Jul 27, 2020Medical Components, Inc dba MedComp
Medcomp 15.SF X 24CM Titan HD CATHETER (CUFF 19CM FROM TIP) Ref: THD155024
Terminated		 MSDK994105
Feb 11, 2020MARVAO MEDICAL DEVICES LTD.
NexSite HD, Hemodialysis Symmetric Tip Catheter for long term use
Open, Classified		 MSDK173805
Jun 14, 2019Bard Peripheral Vascular Inc
EQUISTREAM XK Long-Term Hemodialysis Catheter. REF/UDI:5913190/(01)00801741013836; 16F
Terminated		 MSDK090901
Jun 14, 2019Bard Peripheral Vascular Inc
EQUISTREAM XK Long-Term Hemodialysis Catheter. REF/UDI:5913230/:(01)00801741013843; 16F
Terminated		 MSDK090901
May 31, 2019Bard Peripheral Vascular Inc
GlidePath Long-Term Hemodialysis Catheter with Preloaded stylet, REF/Product code:5397500, 14.5F, straight, 50cm length, BARD, UDI: 00801741012358
Terminated		 MSDK051748
May 31, 2019Bard Peripheral Vascular Inc
GlidePath Long-Term Hemodialysis Catheter with Preloaded stylet, REF/Product code:5397350, 14.5F, straight, 35cm length, BARD, UDI: 00801741012334
Terminated		 MSDK051748
May 31, 2019Bard Peripheral Vascular Inc
GlidePath Long-Term Hemodialysis Catheter with Preloaded stylet, REF/Product code:5397310, 14.5F, straight, 31cm length, BARD, UDI: 00801741012327
Terminated		 MSDK051748
May 31, 2019Bard Peripheral Vascular Inc
GlidePath Long-Term Hemodialysis Catheter with Preloaded stylet, REF/Product code:5397270, 14.5F, straight, 27cm length, BARD, UDI: 00801741012310
Terminated		 MSDK051748
May 31, 2019Bard Peripheral Vascular Inc
GlidePath Long-Term Hemodialysis Catheter with Preloaded stylet, REF/Product code:5397230, 14.5F, straight, 23cm length, BARD, UDI: 00801741012303
Terminated		 MSDK051748
May 31, 2019Bard Peripheral Vascular Inc
GlidePath Long-Term Hemodialysis Catheter with Preloaded stylet, REF/Product code:5397190, 14.5F, straight, 19cm length, BARD, UDI: 00801741012297
Terminated		 MSDK051748
May 31, 2019Bard Peripheral Vascular Inc
GlidePath Long-Term Hemodialysis Catheter, REF/Product code:5396280, 14.5F, Alphacurve, 28cm length, BARD, UDI: 00801741012266
Terminated		 MSDK051748
May 31, 2019Bard Peripheral Vascular Inc
GlidePath Long-Term Hemodialysis Catheter, REF/Product code:5396240, 14.5F, Alphacurve, 19cm length, BARD, UDI: 00801741012259
Terminated		 MSDK051748
May 31, 2019Bard Peripheral Vascular Inc
GlidePath Long-Term Hemodialysis Catheter, REF/Product code:5396190, 14.5F, Alphacurve, 19cm length, BARD, UDI: 00801741012242
Terminated		 MSDK051748
May 31, 2019Bard Peripheral Vascular Inc
GlidePath Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5393420, 14.5F, Straight, 42cm length, BARD, UDI: 00801741012228
Terminated		 MSDK051748
May 31, 2019Bard Peripheral Vascular Inc
GlidePath Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5393270, 14.5F, Straight, 27cm length, BARD, UDI: 00801741012198
Terminated		 MSDK051748
May 31, 2019Bard Peripheral Vascular Inc
GlidePath Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5393230, 14.5F, Straight, 23cm length, BARD, UDI: 00801741012181
Terminated		 MSDK051748
May 31, 2019Bard Peripheral Vascular Inc
GlidePath Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5393190, 14.5F, Straight, 19cm length, BARD, UDI: 00801741012174
Terminated		 MSDK051748
May 31, 2019Bard Peripheral Vascular Inc
EQUISTREAM XK Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5913420, 16F, Straight, 42cm length, BARD, UDI: 00801741013881
Terminated		 MSDK090101
May 31, 2019Bard Peripheral Vascular Inc
EQUISTREAM XK Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5913310, 16F, Straight, 31cm length, BARD, UDI: 00801741013867
Terminated		 MSDK090101
May 31, 2019Bard Peripheral Vascular Inc
EQUISTREAM XK Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5913350, 16F, Straight, 35cm length, BARD, UDI: 00801741013874
Terminated		 MSDK090101
May 31, 2019Bard Peripheral Vascular Inc
EQUISTREAM XK Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5913270, 16F, Straight, 27cm length, BARD, UDI: 00801741013850
Terminated		 MSDK090101
May 31, 2019Bard Peripheral Vascular Inc
EQUISTREAM XK Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5913230, 16F, Straight, 23cm length, BARD, UDI: 00801741013843
Terminated		 MSDK090101
May 31, 2019Bard Peripheral Vascular Inc
EQUISTREAM XK Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5913190, 16F, Straight, 19cm length, BARD, UDI: 00801741013836
Terminated		 MSDK090101
May 31, 2019Bard Peripheral Vascular Inc
EQUISTREAM XK Alphacurve Long-Term Hemodialysis Catheter REF/Product code:5915240, 16F, 24cm length, BARD, UDI: 00801741013904
Terminated		 MSDK090101
May 31, 2019Bard Peripheral Vascular Inc
EQUISTREAM Long-Term Hemodialysis Catheter with Preloaded Styet, REF/Product code:5904270, 14.5F, Straight ,27cm length, BARD, UDI: 00801741013775
Terminated		 MSDK090101
May 31, 2019Bard Peripheral Vascular Inc
EQUISTREAM Long-Term Hemodialysis Catheter with Preloaded Styet, REF/Product code:5903310, 14.5F, Straight ,31cm length, BARD, UDI: 00801741013720
Terminated		 MSDK090101
May 31, 2019Bard Peripheral Vascular Inc
EQUISTREAM Long-Term Hemodialysis Catheter with Preloaded Styet, REF/Product code:5903270, 14.5F, Straight ,27cm length, BARD, UDI: 00801741013713
Terminated		 MSDK090101
May 31, 2019Bard Peripheral Vascular Inc
EQUISTREAM Long-Term Hemodialysis Catheter with Preloaded Styet, REF/Product code:5903230, 14.5F, Straight ,23cm length, BARD, UDI: 00801741013706
Terminated		 MSDK090101
May 31, 2019Bard Peripheral Vascular Inc
EQUISTREAM Long-Term Hemodialysis Catheter with Preloaded Styet, REF/Product code:5903190, 14.5F, Straight ,19cm length, BARD, UDI# 00801741013690
Terminated		 MSDK090101
May 31, 2019Bard Peripheral Vascular Inc
EQUISTREAM LONG-TERM HEMODIALYSIS CATHETER, REF/Product code:5905280, 14.5 Fr. Alphacurve Catheter with Standard Kit, 28cm length, BARD, UDI# 00801741013812
Terminated		 MSDK090101
May 31, 2019Bard Peripheral Vascular Inc
EQUISTREAM LONG-TERM HEMODIALYSIS CATHETER, REF/Product code:5905240, 14.5 Fr. Alphacurve Catheter with Standard Kit, 24cm length, BARD, UDI# 00801741013805
Terminated		 MSDK090101
May 31, 2019Bard Peripheral Vascular Inc
EQUISTREAM LONG-TERM HEMODIALYSIS CATHETER, REF/Product Code:5905190, 14.5 Fr. Alphacurve Catheter with Standard Kit, 19 cm length, BARD, UDI# 00801741013799
Terminated		 MSDK090101
Jul 1, 2015Covidien LLC
Palindrome Precision HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888133509P
Terminated		 MSDK062671
K112477 +1
Jul 1, 2015Covidien LLC
Palindrome Precision HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888128459P
Terminated		 MSDK062671
K112477 +1
Jul 1, 2015Covidien LLC
Palindrome Precision HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888123409P
Terminated		 MSDK062671
K112477 +1
Jul 1, 2015Covidien LLC
Palindrome Precision HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 19cm Item Code: 8888119369P
Terminated		 MSDK062671
K112477 +1
Jul 1, 2015Covidien LLC
Palindrome HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888133509
Terminated		 MSDK062671
K112477
Jul 1, 2015Covidien LLC
Palindrome HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888128459
Terminated		 MSDK062671
K112477
Jul 1, 2015Covidien LLC
Palindrome HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888123409
Terminated		 MSDK062671
K112477
Jul 1, 2015Covidien LLC
Palindrome HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 19cm Item Code: 8888119369
Terminated		 MSDK062671
K112477
Jul 1, 2015Covidien LLC
Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888145050CP
Terminated		 MSDK062671
K112477 +1
Jul 1, 2015Covidien LLC
Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888145050P
Terminated		 MSDK062671
K112477 +1

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