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

Catheter, Peritoneal, Long-Term Indwelling

Regulation 876.5630

0510(k)s in 12 months (48 all time)
0recalls in 12 months (8 all time)
7recalls that name a 510(k)
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Top companies in FJS

Company510(k)sRecalls
Quinton, Inc.80
Accurate Surgical Instruments Co.70
Medigroup, Inc.50
Bard Access Systems04
Janin Group, Inc.40
Merit Medical Systems, Inc.03
Sil-Med Corp.30
Covidien, LLC20
Dravon Medical, Inc.20
Medical Components, Inc.20
DateFirm and productCodeLinked 510(k)
Apr 7, 2023Merit Medical Systems, Inc.
Flex-Neck Catheter External Repair Kit REF CE-1400 LOT CE-1400/A
Open, Classified		 FJSNone listed
Dec 20, 2017Merit Medical Systems, Inc.
Flex-Neck Classic Peritoneal Dialysis Catheter (Pediatric) Product Usage: If the patient is a suitable candidate for peritoneal dialysis (PD) therapy, The Flex-Neck PD Catheter can be implanted eithe
Terminated		 FJSK970159
Sep 20, 2017Merit Medical Systems, Inc.
Flex-Neck Classic Peritoneal Dialysis Catheter 1 Cuff Infant Coiled, Catalog # CF-4235/B
Terminated		 FJSK031351
Dec 12, 2014Pfm Medical Inc
ASEPT 2000 ml Drainage Bag, Ref No. 622280 Product Usage: The ASEPT Drainage Bag is to be used for peritoneal drainage with the ASEPT Peritoneal Drainage Catheter only.
Terminated		 FJSK093796
K113354
Aug 8, 2011Bard Access Systems
Bard Aspira Valve Assembly/Repair Kit, Product Code 4991506. The Aspira Peritoneal Drainage system is indicated for intermittent drainage of recurrent and symptomatic malignant ascites. The catheter
Terminated		 FJSK110396
Aug 8, 2011Bard Access Systems
Bard Aspira Luer Adapter, Product Code 4991505. The Aspira Peritoneal Drainage system is indicated for intermittent drainage of recurrent and symptomatic malignant ascites. The catheter is intended f
Terminated		 FJSK110396
Aug 8, 2011Bard Access Systems
Bard Aspira Dressing Kit, Product Code 4991503. The Aspira Peritoneal Drainage system is indicated for intermittent drainage of recurrent and symptomatic malignant ascites. The catheter is intended f
Terminated		 FJSK110396
Aug 8, 2011Bard Access Systems
Bard Aspira Drainage Kit, Product Code 4991502. The Aspira Peritoneal Drainage system is indicated for intermittent drainage of recurrent and symptomatic malignant ascites. The catheter is intended
Terminated		 FJSK110396

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