# K241115: SV Spectrum MRC Central Venous Catheter; SV Spectrum MR Central Venous Catheter; SV Central Venous Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Spectrum Vascular
- Decided: Nov 27, 2024 after 218 days
- Product code: FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days)
- Device class: 2
- Regulation: 21 CFR 880.5200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K960764 (1997). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223648: Cook® Spectrum® 2 MRC Central Venous Catheter, Cook Advanced Technologies (2023) Summary page 6.

## Indications for use
The SV Spectrum MRC Central Venous Catheter is indicated to provide short-term (<30 days) central venous access intended for: • Continuous or intermittent drug infusion • Central venous blood pressure monitoring (CVP) • Acute hyperalimentation • Blood sampling • Delivery of whole blood or blood products • Simultaneous, separate infusion of drugs • Power injection of contrast media (max 300 psi) The activity of the antimicrobial agents, minocycline, rifampin and chlorhexidine is located at the internal and external catheter surfaces and is not intended for treatment of existing infections. This combination of antimicrobials has been shown to reduce microbial colonization of the catheter. The effectiveness was evaluated using in vitro methods; no correlation between in vitro and clinical outcome has currently been ascertained. Controlled studies of this product have not been conducted in pregnant women, pediatric or neonatal patients. The benefits of the use of this catheter should be weighed against any possible risk. Consider CDC Guidelines and institutional protocols for catheter exchange. The SV Spectrum MR Central Venous Catheter is indicated to provide short-term (<30 days) central venous access intended for: • Continuous or intermittent drug infusion • Central venous blood pressure monitoring (CVP) • Acute hyperalimentation • Blood sampling • Delivery of whole blood or blood products • Simultaneous, separate infusion of drugs and • Power injection of contrast media (max 300 psi). The activity of the antimicrobial agents, minocycline and rifampin is localized at the internal and external catheter surfaces and helps to provide protection against catheter related bloodstream infections (CRBSI). It is not intended for treatment of existing infection. The device is a short-term use catheter. The SV Central Venous Catheter is indicated to provide short- term (<30 days) central venous access intended for: • Continuous or intermittent drug infusion • Central venous blood pressure monitoring (CVP) • Acute hyperalimentation • Blood sampling • Delivery of whole blood or blood products • Simultaneous, separate infusion of drugs and • Power injection of contrast media (max 300 psi).

Source page: https://510kreport.com/device/K241115
Methodology: https://510kreport.com/methodology