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)
Top companies in OWL
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 22, 2026 | Cardinal 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 |
OWL | None listed |
| Jun 13, 2026 | ARROW 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 |
OWL | None listed |
| Apr 22, 2026 | ARROW 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 |
OWL | None listed |
| Jan 29, 2026 | LSL Healthcare Inc. LSL Healthcare, Central Line Dressing Kit, Model/Catalog Number: 2519CP, medical procedure convenience kit Open, Classified |
OWL | None listed |
| Jan 11, 2023 | Stradis Healthcare Vital Care Products NEONATAL PICC TRAY, Sterile, QTY 20. Manufactured for Vital Care Products, Inc. Open, Classified |
OWL | None listed |
| Jan 11, 2023 | Stradis Healthcare Stradis Healthcare NEONATAL PICC Tray *PGBK* 20 trays per case. Manufactured by Stradis Healthcare, Distributed by Med Alliance Group Open, Classified |
OWL | None listed |
| Jan 11, 2023 | Stradis Healthcare PICC KIT, 10/CS, ACCESS MEDICAL LABEL Open, Classified |
OWL | None listed |
| Dec 8, 2022 | Medical 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 |
OWL | None listed |
| Jun 15, 2020 | Access 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 |
OWL | None listed |
| Feb 28, 2018 | Vygon U.S.A. PICC Insertion Tray, Product Code: AMS-7192CS-4
Convenience kit for the insertion of PICCs into the vascular system. Terminated |
OWL | None listed |
| Feb 28, 2018 | Vygon U.S.A. PICC Insertion Tray, Product Code: AMS-7192CS-3
Convenience kit for the insertion of PICCs into the vascular system. Terminated |
OWL | None listed |
| Feb 28, 2018 | Vygon U.S.A. Maximum Barrier Tray, Product Code: MCITX-1
Convenience kit for the insertion of PICCs into the vascular system. Terminated |
OWL | None listed |
| Feb 28, 2018 | Vygon U.S.A. PICC Tray, Product Code: AMS-9093CP
Convenience kit for the insertion of PICCs into the vascular system. Terminated |
OWL | None listed |
| Feb 28, 2018 | Vygon U.S.A. Maximum Barrier Insertion Tray, Product Code: AMS-9152CP
Convenience kit for the insertion of PICCs into the vascular system. Terminated |
OWL | None listed |
| Feb 28, 2018 | Vygon U.S.A. Maximum Barrier Tray, Product Code: AMS-9018CP
Convenience kit for the insertion of PICCs into the vascular system. Terminated |
OWL | None listed |
| Feb 28, 2018 | Vygon U.S.A. Neonatal PICC Tray, Product Code: AMS-8010CP-1
Convenience kit for the insertion of PICCs into the vascular system. Terminated |
OWL | None listed |
| Feb 28, 2018 | Vygon U.S.A. PICC Kit, Product Code: AMS-7063-1
Convenience kit for the insertion of PICCs into the vascular system. Terminated |
OWL | None listed |
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