Spectrum Turbo-Ject PICC Set
510(k) K100974
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK100974 | Date6 May 2010 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- FOZ
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.5200
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Spectrum Turbo-Ject PICC Set is a power-injectable peripherally inserted central catheter (PICC) designed for repeated administration of contrast media. It features an antimicrobial-impregnated catheter to reduce the risk of catheter-related bloodstream infections, incorporating minocycline and rifampin as antimicrobial agents. This device is classified as a single-lumen PICC intended for vascular access in clinical settings requiring frequent contrast injections, such as radiology procedures.
The Spectrum Turbo-Ject PICC Set is supplied in 3 Fr and 6 Fr sizes and is intended for single-use. It is intended for use in general hospital settings and has been cleared under FDA 510(k) as substantially equivalent to prior models. The device is not labeled for MRI compatibility or reuse, and proper storage conditions must be maintained to preserve sterility and functionality. Authorisation details include FDA clearance via 510(k) number K100974, filed under product code FOZ.
Other devices from Cook Incorporated
Questions
AI-generated answers, 19 Sep 2026
What clinical scenarios is the Spectrum Turbo-Ject PICC Set specifically designed for, and why is this important?
The Spectrum Turbo-Ject PICC Set is designed for repeated administration of contrast media in clinical settings where frequent contrast injections are required, such as radiology procedures. This is important because it is a power-injectable peripherally inserted central catheter (PICC) optimized for high-pressure injections, reducing the need for repeated venipunctures and improving efficiency during imaging studies like CT scans or angiograms.
Is the Spectrum Turbo-Ject PICC Set reusable, and if not, what does this mean for clinical workflows?
No, the Spectrum Turbo-Ject PICC Set is intended for single-use only. This means each catheter must be discarded after one use, ensuring sterility and reducing the risk of infection. Clinicians should plan for replacement after use and follow proper disposal protocols to maintain safety and compliance with single-use medical device guidelines.
What antimicrobial features does the Spectrum Turbo-Ject PICC Set include, and how might this benefit patients?
The Spectrum Turbo-Ject PICC Set incorporates an antimicrobial-impregnated catheter with minocycline and rifampin to help reduce the risk of catheter-related bloodstream infections. This feature is particularly beneficial for patients requiring long-term or repeated vascular access, as it lowers infection risks associated with central lines.
What sizes are available for the Spectrum Turbo-Ject PICC Set, and how might this affect patient selection?
The Spectrum Turbo-Ject PICC Set is available in 3 French (Fr) and 6 French (Fr) sizes, allowing for flexibility in patient selection based on vascular anatomy and clinical needs. The 3 Fr size is typically suited for smaller veins or pediatric patients, while the 6 Fr size may be preferred for adults or larger patients requiring higher flow rates or contrast volumes.
How should the Spectrum Turbo-Ject PICC Set be stored to ensure proper functionality and sterility?
The Spectrum Turbo-Ject PICC Set must be stored under controlled conditions to preserve sterility and functionality. Since it is a single-use device, it should remain in its original, unopened packaging until immediately before use. Exposure to moisture, extreme temperatures, or contamination could compromise its integrity, so adherence to manufacturer storage guidelines is critical.