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Panels › General Hospital › Product code OWL · Class 2

Peripheral Catheter Insertion Kit

Regulation 880.5200

0510(k)s in 12 months (0 all time)
4recalls in 12 months (17 all time)
0recalls that name a 510(k)
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Top companies in OWL

DateFirm and productCodeLinked 510(k)
Sep 22, 2026Cardinal Health 200, LLC
Presource Convenience Kits: 1) KIT, USGPIV , Catalog Number: PVMHIVMHD; 2) KIT, USGPIV , Catalog Number: PVMHIVM14; 3) KIT, USGPIV , Catalog Num
Open, Classified
OWLNone listed
Jun 13, 2026ARROW INTERNATIONAL, LLC
Description/REF: MIDLINE CATHETER KIT: 3 FR X 20 CM/CDC-02031-MK1A; AM/AT PI MIDLINE 1L: 4.5FR X 15CM/CDC-41541-MPK1A; AM/AT PI MIDLINE 2L: 5.5FR X 15CM/CDC-41552-MPK1A; AGBA PI MIDLINE 1L: 4.5FR X 15
Open, Classified
OWLNone listed
Apr 22, 2026ARROW INTERNATIONAL, LLC
Arrow Echogenic Introducer Needle REF ASK-04001-BWK2 UDI code: (01)10801902220315(17)261231(11)251210(10)33F25J0347 This device is intended for injection or aspiration of fluids. The needle protectio
Open, Classified
OWLNone listed
Jan 29, 2026LSL Healthcare Inc.
LSL Healthcare, Central Line Dressing Kit, Model/Catalog Number: 2519CP, medical procedure convenience kit
Open, Classified
OWLNone listed
Jan 11, 2023Stradis Healthcare
Vital Care Products NEONATAL PICC TRAY, Sterile, QTY 20. Manufactured for Vital Care Products, Inc.
Open, Classified
OWLNone listed
Jan 11, 2023Stradis Healthcare
Stradis Healthcare NEONATAL PICC Tray *PGBK* 20 trays per case. Manufactured by Stradis Healthcare, Distributed by Med Alliance Group
Open, Classified
OWLNone listed
Jan 11, 2023Stradis Healthcare
PICC KIT, 10/CS, ACCESS MEDICAL LABEL
Open, Classified
OWLNone listed
Dec 8, 2022Medical Action Industries, Inc. 306
Medical Action Industries Inc. Port Access Kit, REF #76511B (on case label), sterile; and Medical Action Industries Inc. IV Start Kit, REF #78019 (on kit label), sterile. Kit components are the Port
Terminated
OWLNone listed
Jun 15, 2020Access Scientific LLC
POWERWAND XL 4Fr 8cm Maximum Barrier Kit (Introducer with an Extended Dwell Catheter made of ChronoFlex C with BioGUARD Technology), Catalog No. 94108, Device UDI 00859821006773/Pacakge UDI 1085982100
Terminated
OWLNone listed
Feb 28, 2018Vygon U.S.A.
PICC Insertion Tray, Product Code: AMS-7192CS-4 Convenience kit for the insertion of PICCs into the vascular system.
Terminated
OWLNone listed
Feb 28, 2018Vygon U.S.A.
PICC Insertion Tray, Product Code: AMS-7192CS-3 Convenience kit for the insertion of PICCs into the vascular system.
Terminated
OWLNone listed
Feb 28, 2018Vygon U.S.A.
Maximum Barrier Tray, Product Code: MCITX-1 Convenience kit for the insertion of PICCs into the vascular system.
Terminated
OWLNone listed
Feb 28, 2018Vygon U.S.A.
PICC Tray, Product Code: AMS-9093CP Convenience kit for the insertion of PICCs into the vascular system.
Terminated
OWLNone listed
Feb 28, 2018Vygon U.S.A.
Maximum Barrier Insertion Tray, Product Code: AMS-9152CP Convenience kit for the insertion of PICCs into the vascular system.
Terminated
OWLNone listed
Feb 28, 2018Vygon U.S.A.
Maximum Barrier Tray, Product Code: AMS-9018CP Convenience kit for the insertion of PICCs into the vascular system.
Terminated
OWLNone listed
Feb 28, 2018Vygon U.S.A.
Neonatal PICC Tray, Product Code: AMS-8010CP-1 Convenience kit for the insertion of PICCs into the vascular system.
Terminated
OWLNone listed
Feb 28, 2018Vygon U.S.A.
PICC Kit, Product Code: AMS-7063-1 Convenience kit for the insertion of PICCs into the vascular system.
Terminated
OWLNone listed

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