Atlas FDA

COOK AND COOK SPECTRUM CENTRAL VENOUS CATHETERS

FDA 510(k) clearance K081113 · decided 2008-07-30

Clearance details

K-number
K081113
Device name
COOK AND COOK SPECTRUM CENTRAL VENOUS CATHETERS
Applicant
Cook, Inc.
Decision
Substantially Equivalent
Date received
2008-04-18
Decision date
2008-07-30
Days to decision
103 days
Clearance type
Traditional
Product code
FOZ
Device class
2
Regulation number
880.5200
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
Bloomington, IN, US
Third-party review
No
Expedited review
No

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BD Saf-T-Intima™ Subcutaneous Catheter System (K251422)Becton Dickinson Infusion Therapy Systems, Inc.2025-10-08
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Recalls involving this device

RecordFirmDate
COOK MEDICAL Cook Spectrum Central Venous Catheter Tray: Reference Part Number C-UTLMY-701 recall (Z-1783-2026)Cook Incorporated2026-04-06
COOK MEDICAL Spectrum Central Venous Catheter Set: Reference Part Number C-UDLM-401J-ABRM- recall (Z-1788-2026)Cook Incorporated2026-04-06
COOK MEDICAL Spectrum Central Venous Tray: Reference Part Number C-UQLMYJ-1001J-RSC-ABRM-H recall (Z-1789-2026)Cook Incorporated2026-04-06
Spectrum Central Venous Catheter Tray, Minocydine/Rifampin Antibiotic Impregnated, Double recall (Z-1097-2011)Cook, Inc.2011-02-23
Spectrum Central Venous Catheter Tray, Minocydine/Rifampin Antibiotic Impregnated, Double recall (Z-1098-2011)Cook, Inc.2011-02-23
Cook Central Venous Catheter Tray, Double Lumen Polyurethane, 4.0Fr/8cm, C-UDLMY-401J-CCT, recall (Z-1099-2011)Cook, Inc.2011-02-23
Cook Central Venous Catheter Tray, Double Lumen Polyurethane, 4.0Fr/12cm, C-UDLMY-401J-RSC recall (Z-1100-2011)Cook, Inc.2011-02-23
Cook Central Venous Catheter Tray, Double Lumen Polyurethane, 5.0Fr/8cm, CUDLMY501JCCT, G2 recall (Z-1101-2011)Cook, Inc.2011-02-23
Cook Central Venous Catheter Tray, Double Lumen Polyurethane, 5.0Fr/12cm, CUDLMY501JRSCCCT recall (Z-1102-2011)Cook, Inc.2011-02-23
Cook Central Venous Catheter Tray, Triple Lumen Polyurethane, 5.0Fr/8cm, CUTLMY501JCCT, G2 recall (Z-1103-2011)Cook, Inc.2011-02-23
Cook Central Venous Catheter Tray, Triple Lumen Polyurethane, 5.0Fr/15cm, CUTLMY501JLSCCCT recall (Z-1104-2011)Cook, Inc.2011-02-23
Cook Central Venous Catheter Tray, Triple Lumen Polyurethane, 5.0Fr/12cm, CUTLMY501JRSCCCT recall (Z-1105-2011)Cook, Inc.2011-02-23
Spectrum Central Venous Catheter Tray Minocycline/Rifampin Antibiotic Impregnated, Double recall (Z-1110-2011)Cook, Inc.2011-02-23
Spectrum Central Venous Catheter Tray Minocycline/Rifampin Antibiotic Impregnated, Double recall (Z-1111-2011)Cook, Inc.2011-02-23
Spectrum Central Venous Catheter Tray Minocycline/Rifampin Antibiotic Impregnated, Double recall (Z-1112-2011)Cook, Inc.2011-02-23
Spectrum Central Venous Catheter Tray Minocycline/Rifampin Antibiotic Impregnated, Double recall (Z-1113-2011)Cook, Inc.2011-02-23
Spectrum Central Venous Catheter Tray Minocycline/Rifampin Antibiotic Impregnated, Double recall (Z-1114-2011)Cook, Inc.2011-02-23
Cook Medical Central Venous Catheter Tray, 5 Lumen Polyurethane, 10Fr/15cm, C-UQLMY-1001J- recall (Z-1115-2011)Cook, Inc.2011-02-23
Cook Medical Central Venous Catheter Tray, 5 Lumen Polyurethane, 10Fr/20cm, CUQLMY1001JRSC recall (Z-1116-2011)Cook, Inc.2011-02-23
Spectrum Central Venous Catheter Tray, Minocycline/Rifampin Antibiotic Impregnated, 5 Lume recall (Z-1118-2011)Cook, Inc.2011-02-23
Spectrum Central Venous Catheter Tray, Minocycline/Rifampin Antibiotic Impregnated, 5 Lume recall (Z-1119-2011)Cook, Inc.2011-02-23
Spectrum Central Venous Catheter Tray, Minocycline/Rifampin Antibiotic Impregnated, 5 Lume recall (Z-1120-2011)Cook, Inc.2011-02-23
Spectrum Central Venous Catheter Tray, Minocycline/Rifampin Antibiotic Impregnated, 5 Lume recall (Z-1121-2011)Cook, Inc.2011-02-23
Spectrum Central Venous Catheter Tray, Minocycline/Rifampin Antibiotic Impregnated, Double recall (Z-1122-2011)Cook, Inc.2011-02-23
Spectrum Central Venous Catheter Tray, Minocycline/Rifampin Antibiotic Impregnated, Double recall (Z-1123-2011)Cook, Inc.2011-02-23
Spectrum Central Venous Catheter Tray, Minocycline/Rifampin Antibiotic Impregnated, Double recall (Z-1124-2011)Cook, Inc.2011-02-23
Spectrum Central Venous Catheter Tray, Minocycline/Rifampin Antibiotic Impregnated, Double recall (Z-1125-2011)Cook, Inc.2011-02-23
Spectrum Central Venous Catheter Tray, Minocycline/Rifampin Antibiotic Impregnated, Double recall (Z-1126-2011)Cook, Inc.2011-02-23
Spectrum Central Venous Catheter Tray, Minocycline/Rifampin Antibiotic Impregnated, Double recall (Z-1127-2011)Cook, Inc.2011-02-23
Spectrum Central Venous Catheter Tray, Minocycline/Rifampin Antibiotic Impregnated, Double recall (Z-1128-2011)Cook, Inc.2011-02-23
Spectrum Central Venous Catheter Tray, Minocycline/Rifampin Antibiotic Impregnated, Double recall (Z-1129-2011)Cook, Inc.2011-02-23
Spectrum Central Venous Catheter Tray, Minocycline/Rifampin Antibiotic Impregnated, Triple recall (Z-1130-2011)Cook, Inc.2011-02-23
Spectrum Central Venous Catheter Tray, Minocycline/Rifampin Antibiotic Impregnated, Triple recall (Z-1131-2011)Cook, Inc.2011-02-23
Spectrum Central Venous Catheter Tray, Minocycline/Rifampin Antibiotic Impregnated, Triple recall (Z-1132-2011)Cook, Inc.2011-02-23
Spectrum Central Venous Catheter Tray, Minocycline/Rifampin Antibiotic Impregnated, Triple recall (Z-1133-2011)Cook, Inc.2011-02-23
Central Venous Catheter Tray, Double Lumen Polyurethane, 4.0 Fr/ 8 cm, C-UDLMY-401J- CHILD recall (Z-1135-2011)Cook, Inc.2011-02-23
Central Venous Catheter Tray, Double Lumen Polyurethane 5.0 Fr/ 8 cm, C-UDLMY-501J- CHILDR recall (Z-1136-2011)Cook, Inc.2011-02-23
Central Venous Catheter Tray, Double Lumen Polyurethane 5.0 Fr/ 12 cm, C-UDLMY-501J- RSC-C recall (Z-1137-2011)Cook, Inc.2011-02-23
Spectrum Central Venous Catheter Tray, Minocycline/Rifampin Antibiotic Impregnated with Mi recall (Z-1140-2011)Cook, Inc.2011-02-23
Spectrum Central Venous Catheter Tray, Minocycline/Rifampin Antibiotic Impregnated with Mi recall (Z-1141-2011)Cook, Inc.2011-02-23
Spectrum Central Venous Catheter Tray, Minocycline/Rifampin Antibiotic Impregnated with Mi recall (Z-1142-2011)Cook, Inc.2011-02-23
Spectrum Central Venous Catheter Tray, Minocycline/Rifampin Antibiotic Impregnated with Mi recall (Z-1143-2011)Cook, Inc.2011-02-23
Spectrum Central Venous Catheter Tray, Minocycline/Rifampin Antibiotic Impregnated with Mi recall (Z-1144-2011)Cook, Inc.2011-02-23
Spectrum Central Venous Tray, Minocycline/Rifampin Impregnated Triple Lumen Polyurethane C recall (Z-1145-2011)Cook, Inc.2011-02-23
Spectrum Central Venous Tray, Minocycline/Rifampin Impregnated Triple Lumen Polyurethane C recall (Z-1146-2011)Cook, Inc.2011-02-23
Spectrum Central Venous Tray, Minocycline/Rifampin Impregnated Triple Lumen Polyurethane C recall (Z-1147-2011)Cook, Inc.2011-02-23
Central Venous Tray, Triple Lumen Polyurethane Catheter, 7.0 Fr/ 15cm, C-UTLMY-701J-CCT-RD recall (Z-1148-2011)Cook, Inc.2011-02-23
Central Venous Tray, Triple Lumen Polyurethane Catheter, 7.0 Fr/ 25cm, C-UTLMY-701J-LSC-CC recall (Z-1149-2011)Cook, Inc.2011-02-23
Central Venous Tray, Triple Lumen Polyurethane Catheter, 7.0 Fr/ 20cm, C-UTLMY-701J-RSC-CC recall (Z-1150-2011)Cook, Inc.2011-02-23
Spectrum Central Venous Tray, Minocycline/Rifampin Impregnated Triple Lumen Polyurethane C recall (Z-1151-2011)Cook, Inc.2011-02-23

PMA approvals by this applicant

RecordFirmDate
Zenith® Iliac Branch (P020018/S064)Cook, Inc.2025-05-30
ZENITH AAA ENDOVASCULAR GRAFT AND H&L-B ONE-SHOT INTRODUCTINO SYSTEM (P020018/S065)Cook, Inc.2025-04-09
Zenith Fenestrated AAA Endovascular Graft (P020018/S063)Cook, Inc.2024-04-29
Zenith® Fenestrated AAA Endovascular Graft, Zenith® Flex AAA Endovascular System (P020018/S061)Cook, Inc.2023-12-14
Zenith® Fenestrated AAA Endovascular Graft (ZFEN), Zenith® Flex AAA Endovascular System (P020018/S062)Cook, Inc.2023-12-13
Zenith Fenestrated AAA Endovascular Graft (P020018/S060)Cook, Inc.2022-01-20
Zenith AAA Endovascular Graft (P020018/S059)Cook, Inc.2020-10-08
ZENITH FLEX AAA ENDOVASCULAR GRAFT (P020018/S055)Cook, Inc.2018-10-10