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Panels › General Hospital › Product code PND · Class 2

Midline Catheter

Regulation 880.5200

1510(k)s in 12 months (13 all time)
4recalls in 12 months (10 all time)
10recalls that name a 510(k)
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Top companies in PND

Company510(k)sRecalls
C.R. Bard, Inc.40
ARROW INTERNATIONAL Inc.03
Bard Access Systems, Inc.03
Becton Dickinson & Company03
Arrow International, Inc. (Subsidiary of Teleflex, Inc.)20
Pfm Medical, Inc.20
Medcomp (Dba Medical Components, Inc.)10
Medical Components, Inc. (dba MedComp)10
Piper Access, LLC10
Terumo Medical Products (Hangzhou) Co., Ltd.10
DateFirm and productCodeLinked 510(k)
Jul 2, 2026Bard Access Systems, Inc.
CK000880 Provena Midline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741188770 S4153108BDP Provena Midline Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741154003 S4153108BP Provena Midline Catheter 3
Open, Classified		 PNDK213203
Jul 2, 2026Bard Access Systems, Inc.
CK000980A PowerMidline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741236150 P4254108 PowerMidline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741129278 P4254108D PowerMidline Catheter 4 Fr Dual-Lumen
Open, Classified		 PNDK162900
Jul 2, 2026Bard Access Systems, Inc.
CK000727 PowerMidline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741138478 CK000729 PowerMidline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741138713 P4153108D PowerMidline Catheter 3 Fr Single-
Open, Classified		 PNDK153393
Jun 13, 2026ARROW INTERNATIONAL, LLC
Description/REF: PI MIDLINE 2L: 5FR X 20CM/CDC-32052-MPKC
Open, Classified		 PNDK213855
Oct 19, 2022ARROW INTERNATIONAL Inc.
ARROW Pressure Injectable Arrowg+ard Blue Advance Two-Lumen Midline Kit, 5.5 Fr, 15 cm, .018 Inch dia., REF ASK-41552-JHVA1. For peripheral access to the venous system for intravenous therapy, blood
Terminated		 PNDK161313
Sep 14, 2020Becton Dickinson & Company
Bard 3F SL PowerMidline Full Kit CE-indicated for short term access to the peripheral venous system for selected intravenous therapies, blood sampling, and power injection of contrast media Ref: P6153
Terminated		 PNDK162900
Sep 14, 2020Becton Dickinson & Company
Bard 3F SL PowerMidline Basic Kit CE-indicated for short term access to the peripheral venous system for selected intravenous therapies, blood sampling, and power injection of contrast media Ref: P615
Terminated		 PNDK162900
Mar 17, 2020Becton Dickinson & Company
PowerGlide ST Midline Catheter Maximal Barrier Kit-18 gauge,10 cm length Catalog Number: ST018101D
Terminated		 PNDK170158
Sep 24, 2019Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.
4Fr x 20cm Single Lumen CT Midline Basic Tray, Product Code: VYML4S1001
Terminated		 PNDK181208
Apr 23, 2019Arrow International Inc
Arrowg+ard Blue Advance Midline Product Code: PR 41541 BAS
Terminated		 PNDK161313

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