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)
Feb 23, 2011	Cook, Inc. Spectrum Central Venous Tray, Minocycline/Rifampin Impregnated Triple Lumen Polyurethane, 5.0 Fr/ 8cm, C-UTLMY-501J-ABRM-HC-IHI-FST, G48113, Sterile, Cook Medical, Cook Incorporated, Bloomington, Terminated	FOZ	K081113
Feb 23, 2011	Cook, Inc. Spectrum Central Venous Tray, Minocycline/Rifampin Impregnated 5 Lumen Polyurethane, 10.0 Fr/ 15cm, C-UQLMY-1001J-ABRM-IHI-FST-A, G448109, Sterile, Cook Medical, Cook Incorporated, Bloomington, I Terminated	FOZ	K081113
Feb 23, 2011	Cook, Inc. Spectrum Central Venous Tray, Minocycline/Rifampin Impregnated 5 Lumen Polyurethane, 10.0 Fr/ 15cm, C-UQLMY-1001J-ABRM-IHI-FST, G48107, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN. Terminated	FOZ	K081113
Feb 23, 2011	Cook, Inc. Spectrum Central Venous Tray, Minocycline/Rifampin Impregnated Double Lumen Polyurethane With Minipuncture Access, 8.0 Fr/ 15cm, C-UDLMY-801J-MNP-ABRM-HC-IHI-FST-A, G48097, Sterile, Cook Medical, Terminated	FOZ	K081113
Feb 23, 2011	Cook, Inc. Spectrum Central Venous Tray, Minocycline/Rifampin Impregnated Double Lumen Polyurethane, 5.0 Fr/ 12cm, C-UDLMY-501J-RSC-ABRM-HC-IHI-FST, G48076, Sterile, Cook Medical, Cook Incorporated, Bloomin Terminated	FOZ	K081113
Feb 23, 2011	Cook, Inc. Spectrum Central Venous Tray, Minocycline/Rifampin Impregnated Double Lumen Polyurethane, 5.0 Fr/ 5cm, C-UDLMY-501J-PED-ABRM-HC-IHI-FST, G48069, Sterile, Cook Medical, Cook Incorporated, Blooming Terminated	FOZ	K081113
Feb 23, 2011	Cook, Inc. Spectrum Central Venous Tray, Minocycline/Rifampin Impregnated Double Lumen Polyurethane, 5.0 Fr/ 15cm, C-UDLMY-501J-LSC-ABRM-HC-IHI-FST, G48067, Sterile, Cook Medical, Cook Incorporated, Bloomin Terminated	FOZ	K081113
Feb 23, 2011	Cook, Inc. Spectrum Central Venous Tray, Minocycline/Rifampin Impregnated Double Lumen Polyurethane, 5.0 Fr/ 8cm, C-UDLMY-501J-ABRM-HC-IHI-FST, G48064, Sterile, Cook Medical, Cook Incorporated, Bloomington, Terminated	FOZ	K081113
Feb 23, 2011	Cook, Inc. Spectrum Central Venous Tray, Minocycline/Rifampin Impregnated Double Lumen Polyurethane, 4.0 Fr/ 12cm, C-UDLMY-401J-RSC-ABRM-HC-IHI-FST, G48061, Sterile, Cook Medical, Cook Incorporated, Bloomin Terminated	FOZ	K081113
Feb 23, 2011	Cook, Inc. Spectrum Central Venous Tray, Minocycline/Rifampin Impregnated Double Lumen Polyurethane, 4.0 Fr/ 5cm, C-UDLMY-401J-PED-ABRM-HC-IHI-FST, G48059, Sterile, Cook Medical, Cook Incorporated, Blooming Terminated	FOZ	K081113
Feb 23, 2011	Cook, Inc. Spectrum Central Venous Tray, Minocycline/Rifampin Impregnated Double Lumen Polyurethane, 4.0 Fr/ 15cm, C-UDLMY-401J-LSC-ABRM-HC-IHI-FST, G448056, Sterile, Cook Medical, Cook Incorporated, Bloomi Terminated	FOZ	K081113
Feb 23, 2011	Cook, Inc. Spectrum Central Venous Tray, Minocycline/Rifampin Impregnated Double Lumen Polyurethane, 4.0 Fr/ 8cm, C-UDLMY-401J-ABRM-HC-IHI-FST, G48053, Sterile, Cook Medical, Cook Incorporated, Bloomington, Terminated	FOZ	K081113
Feb 23, 2011	Cook, Inc. Spectrum Soft Central Venous Tray, Minocycline/Rifampin Impregnated Double Lumen Polyurethane, 4.0 Fr/ 12cm, C-SDLMY-401J-RSC-ABRM-IHI-FST, G48050, Sterile, Cook Medical, Cook Incorporated, Bloom Terminated	FOZ	K033843
Feb 23, 2011	Cook, Inc. Spectrum Central Venous Tray, Minocycline/Rifampin Impregnated Double Lumen Polyurethane, 4.0 Fr/ 8cm, C-SDLMY-401J-ABRM-IHI-FST, G48047, Sterile, Cook Medical, Cook Incorporated, Bloomington, I Terminated	FOZ	K033843
Feb 23, 2011	Cook, Inc. Spectrum Central Venous Tray, Minocycline/Rifampin Impregnated Triple Lumen Polyurethane, 7.0 Fr/ 20cm, C-UTLMY-701J-190-PIG-RSC-ABRM-FST-A-RD, G47846, Sterile, Cook Medical, Cook Incorporated, Terminated	FOZ	K081113
Feb 23, 2011	Cook, Inc. Spectrum Central Venous Catheter Tray, Minocycline/Rifampin Impregnated Triple Lumen Polyurethane, 7.0 Fr/ 15cm, C-UTLMY-701J-190-PIG-ABRM-FST-A-RD, G47845, Sterile, Cook Medical, Cook Incorpora Terminated	FOZ	K081113
Feb 23, 2011	Cook, Inc. Spectrum Central Venous Catheter Tray, Minocycline/Rifampin Impregnated Triple Lumen Polyurethane Catheter With Minipuncture Access, 7.0 Fr/ 20cm, C-UTLMY-701J-RSC-MNP-ABRM-HC-FST-A-RD, G47839, Terminated	FOZ	K081113
Feb 23, 2011	Cook, Inc. Spectrum Central Venous Tray, Minocycline/Rifampin Impregnated Triple Lumen Polyurethane Catheter, 7.0 Fr/ 20cm, C-UTLMY-701J-RSC-ABRM-HC-FST-RD, G47833, 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/ 25cm, C-UTLMY-701J-LSC-ABRM-HC-FST-RD, G47832, 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-UTLMY-701J-ABRM-HC-FST-RD, G47831, Sterile, Cook Medical, Cook Incorporated, Blo Terminated	FOZ	K081113
Feb 23, 2011	Cook, Inc. Central Venous Tray, Triple Lumen Polyurethane Catheter, 7.0 Fr/ 20cm, C-UTLMY-701J-RSC-CCT-RD, G47822, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN. Terminated	FOZ	K081113
Feb 23, 2011	Cook, Inc. Central Venous Tray, Triple Lumen Polyurethane Catheter, 7.0 Fr/ 25cm, C-UTLMY-701J-LSC-CCT-RD, G47818, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN. Terminated	FOZ	K081113
Feb 23, 2011	Cook, Inc. Central Venous Tray, Triple Lumen Polyurethane Catheter, 7.0 Fr/ 15cm, C-UTLMY-701J-CCT-RD, G47815, 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-UTLMY-701J-RSC-ABRM-HC-FST-A-RD, G44128, Sterile, Cook Medical, Cook Incorporate Terminated	FOZ	K081113
Feb 23, 2011	Cook, Inc. Spectrum Central Venous Tray, Minocycline/Rifampin Impregnated Triple Lumen Polyurethane Catheter, 7.0 Fr/ 25cm, C-UTLMY-701J-LSC-ABRM-HC-FST-A-RD, G44127, Sterile, Cook Medical, Cook Incorporate Terminated	FOZ	K081113
Feb 23, 2011	Cook, Inc. Spectrum Central Venous Tray, Minocycline/Rifampin Impregnated Triple Lumen Polyurethane Catheter 7.0 Fr/ 15cm, C-UTLMY-701J-ABRM-HC-FST-A-RD, G44126, Sterile, Cook Medical, Cook Incorporated, Blo Terminated	FOZ	K081113
Feb 23, 2011	Cook, Inc. Spectrum Central Venous Catheter Tray, Minocycline/Rifampin Antibiotic Impregnated with Minipuncture Access, 8.0 Fr/ 25cm, C-UDLMY-801J-LSC-MNP-ABRM-HC-FST-A, G44071, Sterile, Cook Medical, Cook In Terminated	FOZ	K081113
Feb 23, 2011	Cook, Inc. Spectrum Central Venous Catheter Tray, Minocycline/Rifampin Antibiotic Impregnated with Minipuncture Access, 8.0 Fr/ 20cm, C-UDLMY-801J-RSC-MNP-ABRM-HC-FST-A, G44070, Sterile, Cook Medical, Cook In Terminated	FOZ	K081113
Feb 23, 2011	Cook, Inc. Spectrum Central Venous Catheter Tray, Minocycline/Rifampin Antibiotic Impregnated with Minipuncture Access, 8.0 Fr/ 15cm, C-UDLMY-801J-MNP-ABRM-HC-FST-A, G44069, Sterile, Cook Medical, Cook Incorp Terminated	FOZ	K081113
Feb 23, 2011	Cook, Inc. Spectrum Central Venous Catheter Tray, Minocycline/Rifampin Antibiotic Impregnated with Minipuncture Access, 8.0 Fr/ 20cm, C-UDLMY-801J-RSC-MNP-ABRM-HC-FST, G44067, Sterile, Cook Medical, Cook Inco Terminated	FOZ	K081113
Feb 23, 2011	Cook, Inc. Spectrum Central Venous Catheter Tray, Minocycline/Rifampin Antibiotic Impregnated with Minipuncture Access, 8.0 Fr/ 15cm, C-UDLMY-801J-MNP-ABRM-HC-FST, G44066, Sterile, Cook Medical, Cook Incorpor Terminated	FOZ	K081113
Feb 23, 2011	Cook, Inc. Central Venous Catheter Tray, Polyurethane Catheter, 4.0 Fr/ 9cm, C-PUMY-401J-CHILDRENS-A-HCT, G44044, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN. Terminated	FOZ	None listed
Feb 23, 2011	Cook, Inc. Central Venous Catheter Tray, Polyurethane Catheter, 3.0 Fr/ 8 cm, C-PUMY-301J-CHILDRENS-HCT, G44042, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN. Terminated	FOZ	None listed
Feb 23, 2011	Cook, Inc. Central Venous Catheter Tray, Double Lumen Polyurethane 5.0 Fr/ 12 cm, C-UDLMY-501J- RSC-CHILDRENS-HCT, G44041, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN. Terminated	FOZ	K081113
Feb 23, 2011	Cook, Inc. Central Venous Catheter Tray, Double Lumen Polyurethane 5.0 Fr/ 8 cm, C-UDLMY-501J- CHILDRENS-HCT, G44040, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN. Terminated	FOZ	K081113
Feb 23, 2011	Cook, Inc. Central Venous Catheter Tray, Double Lumen Polyurethane, 4.0 Fr/ 8 cm, C-UDLMY-401J- CHILDRENS-HCT, G44038, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN. Terminated	FOZ	K081113
Feb 23, 2011	Cook, Inc. Spectrum Central Venous Catheter Tray, Minocycline/Rifampin Antibiotic Impregnated, Triple Lumen Polyurethane, 5.0 Fr /15 cm, C-UTLMY-501J- LSC-ABRM-HC-FST, G44016, Sterile, Cook Medical, Cook Incor Terminated	FOZ	K081113
Feb 23, 2011	Cook, Inc. Spectrum Central Venous Catheter Tray, Minocycline/Rifampin Antibiotic Impregnated, Triple Lumen Polyurethane, 5.0 Fr /12 cm, C-UTLMY-501J- RSC-ABRM-HC-FST, G44015, Sterile, Cook Medical, Cook Incor Terminated	FOZ	K081113
Feb 23, 2011	Cook, Inc. Spectrum Central Venous Catheter Tray, Minocycline/Rifampin Antibiotic Impregnated, Triple Lumen Polyurethane, 5.0 Fr /5 cm, C-UTLMY-501J- PED-ABRM-HC-FST, G44014, Sterile, Cook Medical, Cook Incorp Terminated	FOZ	K081113
Feb 23, 2011	Cook, Inc. Spectrum Central Venous Catheter Tray, Minocycline/Rifampin Antibiotic Impregnated, Triple Lumen Polyurethane, 5.0 Fr /8 cm, C-UTLMY-501J- ABRM-HC-FST, G44013, Sterile, Cook Medical, Cook Incorporat Terminated	FOZ	K081113
Feb 23, 2011	Cook, Inc. Spectrum Central Venous Catheter Tray, Minocycline/Rifampin Antibiotic Impregnated, Double Lumen Polyurethane, 5.0 Fr 15 cm, C-UDLMY-501J- LSC-ABRM-HC-FST, G44004, Sterile, Cook Medical, Cook Incorp Terminated	FOZ	K081113
Feb 23, 2011	Cook, Inc. Spectrum Central Venous Catheter Tray, Minocycline/Rifampin Antibiotic Impregnated, Double Lumen Polyurethane, 5.0 Fr12cm, C-UDLMY-501J- RSC-ABRM-HC-FST, G44003, Sterile, Cook Medical, Cook Incorpor Terminated	FOZ	K081113
Feb 23, 2011	Cook, Inc. Spectrum Central Venous Catheter Tray, Minocycline/Rifampin Antibiotic Impregnated, Double Lumen Polyurethane, 4.0 Fr/15 cm, C-UDLMY-401J- LSC-ABRM-HC-FST, G43994, Sterile, Cook Medical, Cook Incorp Terminated	FOZ	K081113
Feb 23, 2011	Cook, Inc. Spectrum Central Venous Catheter Tray, Minocycline/Rifampin Antibiotic Impregnated, Double Lumen Polyurethane, 4.0 Fr/12 cm, C-UDLMY-401J- RSC-ABRM-HC-FST, G43993, Sterile, Cook Medical, Cook Incorp Terminated	FOZ	K081113
Feb 23, 2011	Cook, Inc. Spectrum Central Venous Catheter Tray, Minocycline/Rifampin Antibiotic Impregnated, Double Lumen Polyurethane, 4.0 Fr/5 cm, C-UDLMY-401J- PED-ABRM-HC-FST, G43992, Sterile, Cook Medical, Cook Incorpo Terminated	FOZ	K081113
Feb 23, 2011	Cook, Inc. Spectrum Central Venous Catheter Tray, Minocycline/Rifampin Antibiotic Impregnated, Double Lumen Polyurethane, 4.0 Fr/8 cm, C-UDLMY-401J- ABRM-HC-FST, G43991, Sterile, Cook Medical, Cook Incorporate Terminated	FOZ	K081113
Feb 23, 2011	Cook, Inc. Spectrum Central Venous Catheter Tray, Minocycline/Rifampin Antibiotic Impregnated, Double Lumen Polyurethane, 5.0 Fr/5 cm, CUDLMY501JPED- ABRM-HC-FST, G43982, Sterile, Cook Medical, Cook Incorporat Terminated	FOZ	K081113
Feb 23, 2011	Cook, Inc. Spectrum Central Venous Catheter Tray, Minocycline/Rifampin Antibiotic Impregnated, Double Lumen Polyurethane, 5.0 Fr/8 cm, CUDLMY501JABRM-HC-FST, G43981, Sterile, Cook Medical, Cook Incorporated, B Terminated	FOZ	K081113
Feb 23, 2011	Cook, Inc. Spectrum Central Venous Catheter Tray, Minocycline/Rifampin Antibiotic Impregnated, 5 Lumen Polyurethane, 10.0Fr/25cm, CUQLMY1001JLSCABRMFSTA, G43135, Sterile, Cook Medical, Cook Incorporated, Bloomin Terminated	FOZ	K081113
Feb 23, 2011	Cook, Inc. Spectrum Central Venous Catheter Tray, Minocycline/Rifampin Antibiotic Impregnated, 5 Lumen Polyurethane, 10.0Fr/20cm, CUQLMY1001JRSCABRMFSTA, G43132, Sterile, Cook Medical, Cook Incorporated, Bloomin Terminated	FOZ	K081113

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