Panels › General Hospital › Product code FOZ · Class 2
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Regulation 880.5200
9510(k)s in 12 months (508 all time)
6recalls in 12 months (394 all time)
359recalls that name a 510(k)
Top companies in FOZ
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 5, 2018 | Arrow International Inc Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter, Sharps Safety Features, and Maximal Barrier Precautions.
Permits venous acc Terminated |
FOZ | K071538 |
| Mar 5, 2018 | Arrow International Inc Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue FlexTip Catheter, Sharps Safety Features and Maximal Barrier Precautions.
Permits venous access and catheter introduction Terminated |
FOZ | K071538 |
| Feb 20, 2018 | Arrow International Inc ARROWg+ard Blue Plus Multi Lumen CVC (Central venous catheter); Product Code: AK-45703-ACDC; Exp. Dates Feb 2018 - Nov 2018 Terminated |
FOZ | K993691 |
| Feb 20, 2018 | Arrow International Inc AGB+ Multi Lumen Central Venous Catheterization Kit; Product Codes: CDC-42703-XP1A and CDC-47702-XP1A; Exp. Dates Feb 2018 - Nov 2018 Terminated |
FOZ | K071538 |
| Feb 20, 2018 | Arrow International Inc Pressure Injectable ARROWg+ard Blue PLUS Multi Lumen Central Venous
Catheterization Kit; Product code: ASK-45703-PHF2; Exp. Dates Feb 2018 - Nov 2018 Terminated |
FOZ | K071538 |
| Feb 20, 2018 | Arrow International Inc Pressure Injectable Multi Lumen Central Venous Catheterization Kit with Blue
FlexTip Catheter and Sharps Safety Features;
Product Code: ASK-15703-PRWJ; Exp. Dates Feb 2018- Nov 2018 Terminated |
FOZ | K071538 |
| Feb 20, 2018 | Arrow International Inc Pressure Injectable ARROWg+ard Blue PLUS MultiLumen Central Venous Catheterization Kit; Product Codes: ASK-45703-PNHS; ASK-45703-PGMCL; ASK-45703-PNW; Exp. Dates Feb 2018 - Nov 2018 Terminated |
FOZ | K071538 |
| Feb 20, 2018 | Arrow International Inc Pressure Injectable ARROWg+ard Blue PLUS Multi Lumen Central Venous Catheterization Kit; Product Code: ASK 42703 PUHC; Exp. Dates Feb 2018 - Nov 2018 Terminated |
FOZ | K071538 |
| Dec 22, 2017 | Arrow International Inc AGB+ Multi Lumen CVC Kit (1) Part Number (PN): CDC-42703-B1A, (2) PN: CDC-42802-1A, (3) CDC-45703-1A, (4) CDC-45703-A1A, (5) PN: CDC-45703-B1A; AGB+ Quad-Lumen CVC Kit (6) PN: CDC-42854-1A, (7) PN: CD Terminated |
FOZ | K993691 |
| Dec 22, 2017 | Arrow International Inc ARROWg+ard Blue CVC Kit (1) Part Number (PN): CDC-24301-1A, (2) PN: CDC-24306-1A; (3) ARROWg+ard Blue Large-Bore Multi-Lumen CVC Kit, PN: CDC-22123-1A; (4) Central Venous Catheterization Kit with Blu Terminated |
FOZ | K900263 |
| Dec 22, 2017 | Arrow International Inc AGB+ Multi Lumen Central Venous Catheterization (CVC) Kit (1) Part Number: AK-42703-P1A; (2) AK-45703-P1A; (3) AK-45703-PB1A; AGB+ Pressure Injectable Multi-Lumen CVC Kit (4) CA-42703-P1A; (5) CA-4285 Terminated |
FOZ | K071538 |
| Dec 22, 2017 | Arrow International Inc (1) ARROWg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters, Product Number: ASK-21142-RH; (2) Arrowg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit Terminated |
FOZ | K011761 |
| Dec 22, 2017 | Arrow International Inc (1) MAC Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters, Product Number: ASK-11242-PHP; (2) Arrow MAC" Two- Lumen Central Venous Access Kit, Product Number: CDC-11242-1A Terminated |
FOZ | K002507 |
| Nov 27, 2017 | Arrow International Inc ARROWg+ard BLUE PLUS
Pressure Injectable Quad- Lumen CVC Kit
Product Usage:
The Arrow CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions Terminated |
FOZ | K071538 |
| Nov 27, 2017 | Arrow International Inc ARROWg+ard BLUE PLUS
Pressure Injectable Two- Lumen CVC Kit
Product Usage:
The Arrow CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions Terminated |
FOZ | K071538 |
| Nov 27, 2017 | Arrow International Inc AGB+ Pressure Injectable Multi- Lumen CVC Kit
Product Usage:
The Arrow CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring centr Terminated |
FOZ | K071538 |
| Nov 27, 2017 | Arrow International Inc ARROWg+ard Blue
Product Usage:
The Arrow CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access including, bu Terminated |
FOZ | K011761 |
| Nov 27, 2017 | Arrow International Inc ARROWg+ard Blue Large-Bore Multi-Lumen CVC Kit
Product Usage:
The Arrow CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring cent Terminated |
FOZ | K900263 |
| Nov 27, 2017 | Arrow International Inc ARROWg+ard Blue MAC" Two-Lumen Central Venous Access Kit
Product Usage:
The Arrow CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requ Terminated |
FOZ | K011761 |
| Nov 27, 2017 | Arrow International Inc AGB+ Pressure Injectable Quad- Lumen CVC Kit
Product Usage:
The Arrow CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring centra Terminated |
FOZ | K071538 |
| Nov 27, 2017 | Arrow International Inc AGB+ Pressure Injectable Multi- Lumen CVC Kit
Product Usage:
The Arrow CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring centr Terminated |
FOZ | K071538 |
| Nov 27, 2017 | Arrow International Inc Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R)
Product Usage:
The Arrow CVC is indicated to provide short-term (< 30 days) central v Terminated |
FOZ | K071538 |
| Nov 27, 2017 | Arrow International Inc Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R)
Catheter and Sharps Safety Features
Product Usage:
The Arrow CVC is indicated to prov Terminated |
FOZ | K071538 |
| Nov 27, 2017 | Arrow International Inc Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter and Sharps Safety Features
Product Usage:
The Arrow CVC is indicated to provide short-term (< 30 days) central venous acce Terminated |
FOZ | K071538 |
| Jul 31, 2017 | Cook Inc. Spectrum Central Venous Catheter Tray Minocycline/Rifampin Antibiotic Impregnated, Catalog Identifiers: C-UTLMY-501J-ABRM-HC-FST and C-UTLMY-501J-ABRM-HC-IHI-FST
Usage:
The Spectrum Central Venous Ca Terminated |
FOZ | K033843 |
| Jul 31, 2017 | Cook Inc. Central Venous Tray Triple Lumen Polyurethane Catheter, Catalog Identifier: C-UTLMY-501J-CCT
Product Usage:
The central venous catheter is designed for treatment of critically ill patients and is sug Terminated |
FOZ | None listed |
| Jul 31, 2017 | Cook Inc. Central Venous Catheter Set Heparin Coated Triple Lumen Polyurethane, Catalog Identifiers: C-UTLM-501J-25-6.5-WCE-BH, C-UTLM-501J-BH
Product Usage:
The central venous catheter is designed for treatme Terminated |
FOZ | None listed |
| Jul 31, 2017 | Cook Inc. Central Venous Catheter Tray Triple Lumen Polyurethane, Catalog Identifier: C-UTLMYJ-501J
Product Usage:
The central venous catheter is designed for treatment of critically ill patients and is sugges Terminated |
FOZ | None listed |
| Jul 31, 2017 | Cook Inc. Central Venous Catheter Set Triple Lumen Polyurethane, Catalog Identifier: C-UTLM-501J
Product Usage:
The central venous catheter is designed for treatment of critically ill patients and is suggested Terminated |
FOZ | None listed |
| May 9, 2017 | Arrow International Inc ARROWg+ard Blue CVC Kit
The ARROWg+ard Blue CVCs are intended to permit venous access to the central circulation Terminated |
FOZ | K900263 |
| May 9, 2017 | Arrow International Inc Arrow MAC Two-Lumen Central Venous Access Kit
Introducer Catheter
The Arrow Two-Lumen Central Venous Access device permits venous access and catheter introduction to the central circulation Terminated |
FOZ | K002507 |
| May 9, 2017 | Arrow International Inc 1) ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit
2) ARROWg+ard Blue PSI Kit
3) ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit
4) ARROWg+ard Blue PSI Kit
The MACTM two-Lumen Cent Terminated |
FOZ | K011761 |
| May 9, 2017 | Arrow International Inc Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features.
The multiple-lumen catheter permits venous access to the central circ Terminated |
FOZ | K993691 |
| May 9, 2017 | Arrow International Inc 1) Pressure Injectable Multi-Lumen Central Venous Catheterization Kit
2) Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter and Sharps Safety Features
3 Terminated |
FOZ | K071538 |
| Apr 10, 2017 | Arrow International Inc Pressure Injectable Arrowg+ard Blue Plus Multi-Lumen Central Venous Catheterization Kit.
Permits venous access to central circulation by way of subclavian, jugular and femoral veins. The ARROWg+ard te Terminated |
FOZ | K071538 |
| Mar 20, 2017 | Arrow International Inc ARROWg+ard Blue You-Bend Two-Lumen Hemodialysis Catheterization Kit for High Volume Infusions
The Arrow(r) CVC is indicated to provide short-term ( < 30 days) central venous access for treatment of d Terminated |
FOZ | K002507 |
| Mar 20, 2017 | Arrow International Inc ARROWg+ard Blue You-Bend Two-Lumen Hemodialysis Catheterization Kit for High Volume Infusions
The Arrow(r) CVC is indicated to provide short-term ( < 30 days) central venous access for treatment of d Terminated |
FOZ | K002507 |
| Mar 20, 2017 | Arrow International Inc Two-Lumen Hemodialysis Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue(R) Catheter, Sharps Safety Features and Maximal Barrier Precautions for High Volume Infusions
The Arrow(r) CVC is indi Terminated |
FOZ | K002507 |
| Mar 20, 2017 | Arrow International Inc ARROWg+ard Blue PLUS(R) Two-Lumen Central Venous Catheterization Kit
The Arrow(r) CVC is indicated to provide short-term ( < 30 days) central venous access for treatment of diseases or conditions req Terminated |
FOZ | K002507 |
| Mar 20, 2017 | Arrow International Inc Percutaneous Sheath Introducer Kit with ARROWg+ard Blue(R) Sheath, Integral Hemostasis Valve/Side Port, Sharps Safety Features and Maximal Barrier Precautions for use with 7.5-8 Fr. Catheters
The A Terminated |
FOZ | K002507 |
| Mar 20, 2017 | Arrow International Inc ARROWg+ard Blue Large-Bore Multi-Lumen CVC Kit
The large-bore multiple-lumen catheter permits venous access to the central circulation for rapid fluid administration. It may be inserted into the ju Terminated |
FOZ | K002507 |
| Mar 20, 2017 | Arrow International Inc Arterial Line Kit with Sharps Safety Features and Maximal Barrier Precautions
The Arrow Arterial Catheterization device permits access to the peripheral arterial circulation or to other small vessels Terminated |
FOZ | K002507 |
| Mar 20, 2017 | Arrow International Inc QuickFlash(R) Radial Artery/Arterial Line Catheterization Kit
The Arrow Arterial Catheterization device permits access to the peripheral arterial circulation or to other small vessels Terminated |
FOZ | K002507 |
| Mar 20, 2017 | Arrow International Inc Arterial Catheterization Kit
The Arrow Arterial Catheterization device permits access to the peripheral arterial circulation or to other small vessels Terminated |
FOZ | K002507 |
| Mar 20, 2017 | Arrow International Inc Arterial Catheterization Kit with Maximal Barrier Precautions
The Arrow Arterial Catheterization device permits access to the peripheral arterial circulation or to other small vessels Terminated |
FOZ | K002507 |
| Mar 20, 2017 | Arrow International Inc QuickFlash Radial Artery/Arterial Line Catheterization Kit
The Arrow Arterial Catheterization device permits access to the peripheral arterial circulation or to other small vessels Terminated |
FOZ | K002507 |
| Mar 20, 2017 | Arrow International Inc Radial Artery Catheterization Kit with Sharps Safety Features
The Arrow Arterial Catheterization device permits access to the peripheral arterial circulation or to other small vessels Terminated |
FOZ | K002507 |
| Mar 20, 2017 | Arrow International Inc Radial Artery Catheterization Kit with Sharps Safety Features
The Arrow Arterial Catheterization device permits access to the peripheral arterial circulation or to other small vessels Terminated |
FOZ | K002507 |
| Mar 20, 2017 | Arrow International Inc Femoral Arterial Line Catheterization Kit
The Arrow Arterial Catheterization device permits access to the peripheral arterial circulation or to other small vessels Terminated |
FOZ | K002507 |
| Mar 20, 2017 | Arrow International Inc Femoral Arterial Line Catheterization Kit
The Arrow Arterial Catheterization device permits access to the peripheral arterial circulation or to other small vessels Terminated |
FOZ | K002507 |
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