510(k) K133634

SPECTRUM TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SET by Cook, Inc. — Product Code LJS

K133634 is an FDA 510(k) premarket notification submitted by Cook, Inc. for the device "SPECTRUM TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SET". The FDA issued a decision of Substantially Equivalent on December 23, 2013. The device falls under product code LJS (Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days), a Class II device regulated under 21 CFR 880.5970. Cook, Inc. has at least 10 other 510(k) clearances on record.