Cook Medical nets FDA clearance for Spectrum power injection indications

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The FDA has granted 510(k) clearance to Cook Medical for a power injectable indication for sizes 7-10 French of its Spectrum antibiotic central venous catheters.

The clearance includes power injection indications for the distal lumen of adult Spectrum catheters in 7 French, 8 French, 9 French and 10 French diameters. The FDA clearance does not include power injection indications for Spectrum catheters in pediatric sizes, the Bloomington, Ind.-based company said.

The Spectrum anti-microbial central venous catheter is available for immediate delivery in the United States, according to Cook.