Panels › General Hospital › Product code FOZ · Class 2

Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

Regulation 880.5200

8510(k)s in 12 months (508 all time)

6recalls in 12 months (394 all time)

359recalls that name a 510(k)

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Top companies in FOZ

Company	510(k)s	Recalls
Arrow International, Inc.	1	155
Cook Incorporated	13	123
Becton Dickinson Infusion Therapy Systems, Inc.	30	15
Menlo Care, Inc.	22	0
Am2 Pat, Inc.	1	15
B.Braun Medical, Inc.	12	2
Delta Med Spa	3	11
Parke-Davis Co.	14	0
Becton Dickinson Medical Systems	0	12
Becton Dickinson Vascular Access, Inc.	11	0

Date	Firm and product	Code	Linked 510(k)
Jan 22, 2015	Arrow International Inc Multi-Lumen PI CVC Kit and PSI Kit: 3-L 7 FR X 8 product code: ASK-45703-POSU lot #23F13L0166, exp. 31-Jul-2015: Product Usage: Multi-Lumen PI CVC Kit: An intravascular catheter is a device that co Terminated	FOZ	K071538
Dec 12, 2014	Becton Dickinson & Company BD Insyte Autoguard Catheter An active safety engineered peripheral IV catheter with a retracting needle to reduce accidental needle stick injuries. The safety feature (needle retraction) of this de Terminated	FOZ	None listed
Oct 22, 2014	Vygon Corporation Bionector Needleless connector. Bionector is a multi-purpose catheter accessory; a closed needle-less system permitting blood sampling, intermit ant injection and continuous infusion of fluids or medi Terminated	FOZ	K070705
Jun 19, 2014	Nipro Medical Corporation NIPRO Safe Touch Safety Scalp Vein Set Terminated	FOZ	K011297
May 19, 2014	Arrow International Inc Arrowgard Blue and Arrowgard Blue Plus Pressure Injectable Central Venous Catheter, a multiple-lumen catheter that permits venous access to central circulation. Catalog number ASK-45703-PHF. Terminated	FOZ	K071538
Apr 24, 2014	Arrow International Inc Arrowgard Blue Plus Antimicrobial Multi-lumen Central Venous Catheter, catalogue number AK-45854-CDC. Terminated	FOZ	K993691
Apr 1, 2014	Nipro Medical Corporation NIPRO SafeTouch II Safety AVF Needle, 17G x 1 inch. Item code FS+173230BC. Terminated	FOZ	K032777
Jan 23, 2014	Bard Access Systems Titanium Single Lumen Low-Profile port, with Pre-Attached open-Ended Silicone 6.6Fr Catheter. Product Code 0602180 Usage: The 6.6 Fr Open-Ended Single-Lumen venous catheters is packaged into various Terminated	FOZ	None listed
Jan 23, 2014	Bard Access Systems MRI Low Profile Single Lumen port with Open-Ended 6.6Fr Silicone Catheter. Product Code 0603880. Product Usage: The 6.6 Fr Open-Ended Single-Lumen venous catheters is packaged into various Bard Acess Terminated	FOZ	None listed
Jun 26, 2012	Arrow International Inc Arrow Two-Lumen Central Venous Catheterization Set with Blue FlexTip(R) ARROWgard Blue(R) Catheter Product Usage: The multiple-lumen catheter permits venous access to central circulation. Terminated	FOZ	K900263
Jun 19, 2012	Arrow International Inc Arrow International, Inc. 7FR 3-Lumen Arrowg+ard Blue Plus(R) Pressure Injectable Central Venous Catheter - Catalog number CDC-42703-XP1A The multiple-lumen pressure injectable catheter permits venou Terminated	FOZ	K071538
Feb 23, 2011	Cook, Inc. Spectrum Central Venous Tray Minocycline/Rifampin Impregnated Triple Lumen Polyurethane Catheter, 9 Fr/ 20 cm, C-UTLMY-901J-RSC-ABRM-HC-IHI-FST-A-RD, G51590, Sterile, Cook Medical, Cook Incorporate Terminated	FOZ	K081113
Feb 23, 2011	Cook, Inc. Spectrum Central Venous Tray Minocycline/Rifampin Impregnated Triple Lumen Polyurethane Catheter, 9 Fr/ 25 cm, C-UTLMY-901J-LSC-ABRM-HC-FST-A-RD, G51588, Sterile, Cook Medical, Cook Incorporated, B Terminated	FOZ	K081113
Feb 23, 2011	Cook, Inc. Spectrum Central Venous Tray Minocycline/Rifampin Impregnated Triple Lumen Polyurethane Catheter, 9 Fr/ 20 cm, C-UTLMY-901J-RSC-ABRM-HC-FST-A-RD, G51587, Sterile, Cook Medical, Cook Incorporated, B Terminated	FOZ	K081113
Feb 23, 2011	Cook, Inc. Spectrum Central Venous Tray Minocycline/Rifampin Impregnated Triple Lumen Polyurethane Catheter, 9 Fr/ 15 cm, C-UTLMY-901J-ABRM-HC-FST-A-RD, G51586, Sterile, Cook Medical, Cook Incorporated, Bloom Terminated	FOZ	K081113
Feb 23, 2011	Cook, Inc. Spectrum Central Venous Tray Minocycline/Rifampin Impregnated Triple Lumen Polyurethane Catheter, 9 Fr/ 15 cm, C-UTLMY-901J-ABRM-HC-FST-RD, G51585, Sterile, Cook Medical, Cook Incorporated, Bloomin Terminated	FOZ	K081113
Feb 23, 2011	Cook, Inc. Spectrum Central Venous Catheter Tray Minocycline/Rifampin Impregnated 5 Lumen Polyurethane, 10.0 Fr/ 20 cm, C-UQLMY-1001J-RSC-ABRM-HC-IHI-FST-A-RD, G51548, Sterile, Cook Medical, Cook Incorporated Terminated	FOZ	K081113
Feb 23, 2011	Cook, Inc. Spectrum Central Venous Catheter Tray Minocycline/Rifampin Impregnated 5 Lumen Polyurethane, 10.0 Fr/ 15 cm, C-UQLMY-1001J-ABRM-HC-IHI-FST-A-RD, G51546, Sterile, Cook Medical, Cook Incorporated, Bl Terminated	FOZ	K081113
Feb 23, 2011	Cook, Inc. Spectrum Central Venous Catheter Tray Minocycline/Rifampin Impregnated 5 Lumen Polyurethane, 10.0 Fr/ 20 cm, C-UQLMY-1001J-RSC-ABRM-HC-FST-A-RD, G51545, Sterile, Cook Medical, Cook Incorporated, Bl Terminated	FOZ	K081113
Feb 23, 2011	Cook, Inc. Spectrum Central Venous Catheter Tray Minocycline/Rifampin Impregnated 5 Lumen Polyurethane, 10.0 Fr/ 15 cm, C-UQLMY-1001J--ABRM-HC-FST-A-RD, G51543, Sterile, Cook Medical, Cook Incorporated, Bloom Terminated	FOZ	K081113
Feb 23, 2011	Cook, Inc. Spectrum Central Venous Catheter Tray Minocycline/Rifampin Impregnated 5 Lumen Polyurethane, 10.0 Fr/ 20cm, C-UQLMY-1001J-RSC-ABRM-HC-FST-RD, G51542, Sterile, Cook Medical, Cook Incorporated, Bloom Terminated	FOZ	K081113
Feb 23, 2011	Cook, Inc. Spectrum Central Venous Catheter Tray, Minocycline/Rifampin Antibiotic Impregnated, 5 Lumen Polyurethane, 10 Fr/ 15 cm, C-UQLMY-1001J-ABRM-HC-FST-RD, G51540, Sterile, Cook, Inc., Bloomington, IN. Terminated	FOZ	K081113
Feb 23, 2011	Cook, Inc. Central Venous Catheter Tray Five Lumen Polyurethane, 10.0 Fr/ 20cm, C-UQLMY-1001J-RSC-CCT-RD, G51536, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN. Terminated	FOZ	K081113
Feb 23, 2011	Cook, Inc. Spectrum Central Venous Tray Minocycline/Rifampin Impregnated Triple Lumen Polyurethane Catheter, 7.0 Fr/ 20cm, C-UTLMYJC-701J-RSC-ABRM-HC-IHI-FST-A-RD, G51270, Sterile, Cook Medical, Cook Incorpor Terminated	FOZ	K081113
Feb 23, 2011	Cook, Inc. Spectrum Central Venous Tray Minocycline/Rifampin Impregnated Triple Lumen Polyurethane Catheter, 7.0 Fr/ 25cm, C-UTLMYJC-701J-LSC-ABRM-HC-IHI-FST-A-RD, G51269, Sterile, Cook Medical, Cook Incorpor Terminated	FOZ	K081113
Feb 23, 2011	Cook, Inc. Spectrum Central Venous Tray Minocycline/Rifampin Impregnated Triple Lumen Polyurethane Catheter, 7.0 Fr/ 15cm, C-UTLMYJC-701J-RSC-ABRM-HC-FST-A-RD, G51268, Sterile, Cook Medical, Cook Incorporated Terminated	FOZ	K081113
Feb 23, 2011	Cook, Inc. Spectrum Central Venous Tray Minocycline/Rifampin Impregnated Triple Lumen Polyurethane Catheter, 7.0 Fr/ 15cm, C-UTLMYJC-701J-ABRM-HC-IHI-FST-A-RD, G51267, Sterile, Cook Medical, Cook Incorporated Terminated	FOZ	K081113
Feb 23, 2011	Cook, Inc. Spectrum Central Venous Tray Minocycline/Rifampin Impregnated Triple Lumen Polyurethane Catheter, 7.0 Fr/ 15cm, C-UTLMYJC-701J-ABRM-HC-FST-A-RD, G51265, Sterile, Cook Medical, Cook Incorporated, Bl Terminated	FOZ	K081113
Feb 23, 2011	Cook, Inc. Spectrum Central Venous Tray Minocycline/Rifampin Impregnated Triple Lumen Polyurethane Catheter, 5.0 Fr/ 8 cm, C-UTLMYJC-501J-PED-ABRM-HC-IHI-FST, G51264, Sterile, Cook Medical, Cook Incorporated, Terminated	FOZ	K081113
Feb 23, 2011	Cook, Inc. Spectrum Central Venous Tray Minocycline/Rifampin Impregnated Triple Lumen Polyurethane Catheter, 5.0 Fr/ 8 cm, C-UTLMYJC-501J-ABRM-HC-FST, G51255, Sterile, Cook Medical, Cook Incorporated, Bloomin Terminated	FOZ	K081113
Feb 23, 2011	Cook, Inc. Spectrum Central Venous Tray Minocycline/Rifampin Impregnated Double Lumen Polyurethane Catheter, 8.0 Fr/ 20 cm, C-UDLMY-801J-RSC-ABRM-HC-IHI-FST-A, G50822, Sterile, Cook Medical, Cook Incorporated Terminated	FOZ	K081113
Feb 23, 2011	Cook, Inc. Spectrum Central Venous Tray Minocycline/Rifampin Impregnated Double Lumen Polyurethane Catheter, 8.0 Fr/ 15 cm, C-UDLMY-801J-ABRM-HC-IHI-FST-A, G50821, Sterile, Cook Medical, Cook Incorporated, Bl Terminated	FOZ	K081113
Feb 23, 2011	Cook, Inc. Spectrum Central Venous Tray Minocycline/Rifampin Impregnated Double Lumen Polyurethane Catheter, 8.0 Fr/ 20 cm, C-UDLMY-801J-RSC-ABRM-HC-FST-A, G50820, Sterile, Cook Medical, Cook Incorporated, Bl Terminated	FOZ	K081113
Feb 23, 2011	Cook, Inc. Spectrum Central Venous Tray Minocycline/Rifampin Impregnated Double Lumen Polyurethane Catheter, 7.0 Fr/ 25 cm, C-UDLMY-801J-ABRM-HC-FST-A, G50819, Sterile, Cook Medical, Cook Incorporated, Bloomi Terminated	FOZ	K081113
Feb 23, 2011	Cook, Inc. Spectrum Central Venous Tray Minocycline/Rifampin Impregnated Triple Lumen Polyurethane Catheter, 7.0 Fr/ 25 cm Power Injectable, C-UTLMY-701J-LSC-ABRM-HC-IHI-FST-A-RD, G49807, Sterile, Cook Medica Terminated	FOZ	K081113
Feb 23, 2011	Cook, Inc. Spectrum Central Venous Tray Minocycline/Rifampin Impregnated Triple Lumen Polyurethane Catheter, 7.0 Fr/ 25 cm Power Injectable, C-UTLMY-701J-LSC-ABRM-HC-IHI-FST-RD, G49806, Sterile, Cook Medical, Terminated	FOZ	K081113
Feb 23, 2011	Cook, Inc. Spectrum Central Venous Tray Minocycline/Rifampin Impregnated Triple Lumen Polyurethane Catheter, 7.0 Fr/ 20 cm Power Injectable, C-UTLMY-701J-RSC-ABRM-HC-IHI-FST-RD, G49805, Sterile, Cook Medical, Terminated	FOZ	K081113
Feb 23, 2011	Cook, Inc. Spectrum Central Venous Tray Minocycline/Rifampin Impregnated Triple Lumen Polyurethane Catheter, 7.0 Fr/ 20 cm Power Injectable, C-UTLMY-701J-RSC-ABRM-HC-IHI-FST-A-RD, G49804, Sterile, Cook Medica Terminated	FOZ	K081113
Feb 23, 2011	Cook, Inc. Spectrum Central Venous Tray Minocycline/Rifampin Impregnated Triple Lumen Polyurethane Catheter, 7.0 Fr/ 15 cm Power Injectable, C-UTLMY-701J-ABRM-HC-IHI-FST-A-RD, G49803, Sterile, Cook Medical, C Terminated	FOZ	K081113
Feb 23, 2011	Cook, Inc. Spectrum Central Venous Tray Minocycline/Rifampin Impregnated Triple Lumen Polyurethane Catheter, 7.0 Fr/ 15 cm Power Injectable, C-UTLMY-701J-ABRM-HC-IHI-FST-RD, G49802, Sterile, Cook Medical, Coo Terminated	FOZ	None listed
Feb 23, 2011	Cook, Inc. Spectrum Central Venous Catheter Tray, Minocycline/Rifampin Antibiotic Impregnated, Triple Lumen Polyurethane, 9.0 Fr/ 20cm, C-UTLMY-901J-RSC-ABRM-FSTA-RD, G49010, Sterile, Cook Medical, Cook I Terminated	FOZ	K081113
Feb 23, 2011	Cook, Inc. Spectrum Central Venous Catheter Tray, Minocycline/Rifampin Antibiotic Impregnated, Triple Lumen Polyurethane, 9.0 Fr/ 15cm, C-UTLMY-901J-ABRM-FST-A-RD, G49009, Sterile, Cook Medical, Cook Incorpor Terminated	FOZ	K081113
Feb 23, 2011	Cook, Inc. Spectrum Central Venous Catheter Tray, Minocycline/Rifampin Antibiotic Impregnated, Triple Lumen Polyurethane, 9.0 Fr/ 20 cm, C-UTLMY-901J-RSC-ABRM-FST-RD, G49005, Sterile, Cook Medical, Cook Inco Terminated	FOZ	K081113
Feb 23, 2011	Cook, Inc. Spectrum Central Venous Catheter Tray, Minocycline/Rifampin Antibiotic Impregnated Triple Lumen Polyurethane, 9.0 Fr/ 25cm, C-UTLMY-901J-LSC-ABRM-FST-RD, G49004, Sterile, Cook Medical, Cook Incorpo Terminated	FOZ	K081113
Feb 23, 2011	Cook, Inc. Central Venous Catheter Tray, Triple Lumen Polyurethane, 9.0 Fr/ 25cm, C-UTLMY-901J-LSC-CCT-RD, G48998, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN. Terminated	FOZ	K081113
Feb 23, 2011	Cook, Inc. Central Venous Tray, Triple Lumen Polyurethane, 9.0 Fr/ 15cm, C-UTLMY-901J-CCT-RD, G48997, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN. Terminated	FOZ	K081113
Feb 23, 2011	Cook, Inc. Spectrum Central Venous Tray, Minocycline/Rifampin Impregnated Triple Lumen Polyurethane, 5.0 Fr/ 5cm, C-UTLMY-501J-RSC-ABRM-HC-IHI-FST, G48124, Sterile, Cook Medical, Cook Incorporated, Blooming Terminated	FOZ	K081113
Feb 23, 2011	Cook, Inc. Spectrum Central Venous Tray, Minocycline/Rifampin Impregnated Triple Lumen Polyurethane, 5.0 Fr/ 5cm, C-UTLMY-501J-PED-ABRM-HC-IHI-FST, G48122, Sterile, Cook Medical, Cook Incorporated, Blooming Terminated	FOZ	K081113
Feb 23, 2011	Cook, Inc. Spectrum Central Venous Tray, Minocycline/Rifampin Impregnated Five Lumen Polyurethane, 5.0 Fr/ 15cm, C-UQLMY-1001J-RSC-ABRM-IHI-FST-A, G48120, Sterile, Cook Medical, Cook Incorporated, Bloomingt Terminated	FOZ	K081113
Feb 23, 2011	Cook, Inc. Spectrum Central Venous Tray, Minocycline/Rifampin Impregnated Triple Lumen Polyurethane, 5.0 Fr/ 15cm, C-UTLMY-501J-LSC-ABRM-HC-IHI-FST, G48117, Sterile, Cook Medical, Cook Incorporated, Bloomin Terminated	FOZ	K081113

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