ClearanceBrief
Panels › Gastroenterology, Urology › Product code LFJ · Class 2

Catheter, Subclavian

Regulation 876.5540

0510(k)s in 12 months (65 all time)
1recalls in 12 months (6 all time)
6recalls that name a 510(k)
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Top companies in LFJ

Company510(k)sRecalls
Akcess Medical Products, Inc.120
Quinton, Inc.80
Vas-Cath of Canada , Ltd.80
Shiley, Inc.70
Medical Components, Inc.50
Medical Components, Inc dba MedComp05
Vas-Cath, Inc.50
Medcomp30
Impra, Inc.20
Medsurg Industries, Inc.20
DateFirm and productCodeLinked 510(k)
Jun 13, 2026ARROW INTERNATIONAL, LLC
Description/REF: HEMODIALYSIS KIT: 2-LUMEN 12 FR X 16 CM/AK-12122-F
Open, Classified		 LFJK895417
Mar 13, 2019Medical Components, Inc dba MedComp
14F x 30CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061425 Product Usage: An aid for introducing a hemodialysis catheter
Terminated		 LFJK893439
Mar 13, 2019Medical Components, Inc dba MedComp
14F x 24CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061424 Product Usage: An aid for introducing a hemodialysis catheter
Terminated		 LFJK893439
Mar 13, 2019Medical Components, Inc dba MedComp
14F x 20CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061423 Product Usage: An aid for introducing a hemodialysis catheter
Terminated		 LFJK893439
Mar 13, 2019Medical Components, Inc dba MedComp
14F SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061422
Terminated		 LFJK893439
Feb 10, 2015Medical Components, Inc dba MedComp
Hemodialysis Catheters and PICCs: Product identification: MCDLTSL24P (SF X 24CM LT HEMO-CATH), MC061422 (14FX15CM SLX DBL LMN ST CATH), MRCTP41017 (4F X 55CM SINGLE CT PICC), MRCTP52007 (5F DUAL PRO
Terminated		 LFJK890029
K893439

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