510(k) K072625 ยท LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC)
| Applicant | Cook, Inc., Bloomington IN, US |
| Decision | Substantially Equivalent, Dec 13, 2007 |
| Received | Sep 17, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K072625
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 23, 2011 | Cook, Inc. Turbo-Ject PICC Tray, Power Injectable, Polyurethane Peripherally Inserted Central Venous Catheter,
5.0 Fr/ 60 cm, UPICSY-5.0-CT-NT, G49163, Sterile, Cook Medical, Cook Incorporated, Bloomington Terminated |
LJS | None listed |
| Feb 23, 2011 | Cook, Inc. Turbo-Ject PICC Tray, Power Injectable, Polyurethane Peripherally Inserted Central Venous Catheter,
5.0 Fr/ 60 cm, UPICSY-5.0-CT-OTW, G49164, Sterile, Cook Medical, Cook Incorporated, Bloomingt Terminated |
LJS | None listed |
| Feb 23, 2011 | Cook, Inc. Turbo-Ject PICC Tray, Power Injectable, Polyurethane Peripherally Inserted Central Venous Catheter, ,
5.0 Fr/ 60 cm, UPICDSY-5.0-CT, G49168, Sterile, Cook Medical, Cook Incorporated, Bloomingto Terminated |
LJS | None listed |
| Feb 23, 2011 | Cook, Inc. Turbo-Ject PICC Tray, Power Injectable, Polyurethane Peripherally Inserted Central Venous Catheter,
5.0 Fr/ 60 cm, UPICDSY-5.0-CT-NT, G49169, Sterile, Cook Medical, Cook Incorporated, Bloomingto Terminated |
LJS | None listed |
| Feb 23, 2011 | Cook, Inc. Turbo-Ject PICC Tray, Power Injectable, Polyurethane Peripherally Inserted Central Venous Catheter,
5.0 Fr/ 9 cm, UPICDSY-5.0-CT-OTW, G49170, Sterile, Cook Medical, Cook Incorporated, Bloomingto Terminated |
LJS | None listed |
| Feb 23, 2011 | Cook, Inc. Turbo-Ject PICC Tray, Power Injectable, Polyurethane Peripherally Inserted Central Venous Catheter,
4.0 Fr/ 60 cm, UPICSY-4.0-CT-NT, G49175, Sterile, Cook Medical, Cook Incorporated, Bloomington Terminated |
LJS | None listed |
| Feb 23, 2011 | Cook, Inc. Turbo-Ject PICC Tray, Power Injectable, Polyurethane Peripherally Inserted Central Venous Catheter, ,
4.0 Fr/ 60 cm, UPICSY-4.0-CT-OTW, G49176, Sterile, Cook Medical, Cook Incorporated, Blooming Terminated |
LJS | None listed |
| Feb 23, 2011 | Cook, Inc. Turbo-Ject PICC Tray, Power Injectable, Polyurethane Peripherally Inserted Central Venous Catheter,
4.0 Fr/ 60 cm, UPICDSY-4.0-CT, G49180, Sterile, Cook Medical, Cook Incorporated, Bloomington, Terminated |
LJS | None listed |
| Feb 23, 2011 | Cook, Inc. Turbo-Ject PICC Tray, Power Injectable, Polyurethane Peripherally Inserted Central Venous Catheter,
4.0 Fr/ 60 cm, UPICDSY-4.0-CT-NT, G49181, Sterile, Cook Medical, Cook Incorporated, Bloomingt Terminated |
LJS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.