510(k) K033843 ยท FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
SPECTRUM CENTRAL VENOUS CATHETER WITH OR WITHOUT HYDROPHILIC COATING
| Applicant | Cook, Inc., Bloomington IN, US |
| Decision | Substantially Equivalent, Aug 12, 2004 |
| Received | Dec 10, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K033843
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 6, 2026 | Cook Incorporated COOK MEDICAL Spectrum Central Venous Catheter Set: Reference Part Number C-UDLM-401J-ABRM-HC, Order Number G43983;
Reference Part Number C-UDLM-401J-ABRM-HC-CAH, Order Number G24754;
Reference Part Open, Classified |
FOZ | None listed |
| Mar 6, 2020 | Cook Inc. Spectrum Central Venous Catheter Tray, Irrigation Catheter, Reference Part Number C-UDLMY-401 J-ABRM-HC-IHl-FST, Order Number G48053 Terminated |
FOZ | None listed |
| 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 | None listed |
| Dec 12, 2016 | Cook Inc. Cook Spectrum Minocycline/Rifampin Impregnated Double Lumen Central Venous Catheter Tray
Cook Spectrum Minocycline/Rifampin Impregnated Triple Lumen Central Venous Catheter Tray Terminated |
FOZ | None listed |
| Feb 23, 2011 | Cook, Inc. Spectrum Soft Central Venous Catheter Tray Minocyciine/Rifampin Antibiotic Impregnated, Double lumen Polyurethane, 4.0Fr/8cm, CSDLMY 401 JABRMFST, G29413, Sterile, Cook Medical, Cook Incorporated, Blo Terminated |
FOZ | None listed |
| Feb 23, 2011 | Cook, Inc. Spectrum Soft Central Venous Catheter Tray Minocycline/Rifampin Antibiotic Impregnated, Double lumen Polyurethane, 4.0Fr/15cm, CSDLMY401JLSCABRMFST, G29416, Sterile, Cook Medical, Cook Incorporated, B Terminated |
FOZ | None listed |
| Feb 23, 2011 | Cook, Inc. Spectrum Soft Central Venous Catheter Tray Minocycline/Rifampin Antibiotic Impregnated, Double lumen Polyurethane, 4.0Fr/5cm, CSDLMY401JPEDABRMFST, G29418, Sterile, Cook Medical, Cook Incorporated, Bl Terminated |
FOZ | None listed |
| Feb 23, 2011 | Cook, Inc. Spectrum Soft Central Venous Catheter Tray Minocyciine/Rifampin Antibiotic Impregnated, Double lumen Polyurethane, 4.0Fr/12cm, C-SDLMY-401J-RSC-ABRM-FST, G29420, Sterile, Cook Medical, Cook Incorporat Terminated |
FOZ | None listed |
| 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 | None listed |
| 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.