Class Class II
Cook® Spectrum® 2 MRC Central Venous Catheter (K223648)
Description
Cook® Spectrum® 2 MRC Central Venous Catheter by Cook Advanced Technologies, an FDA 510(k) cleared general hospital device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK223648
Clearance Date2023-02-03
Clearance TypeTraditional
Product CodeFOZ
Regulation Number880.5200
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223648
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Cook® Spectrum® 2 MRC Central Venous Catheter (K223648) cites 2 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K081113 | COOK AND COOK SPECTRUM CENTRAL VENOUS CATHETERS | Cook, Inc. | 2008 |
| K071538 | ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTA... | Arrow International, Inc. | 2007 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K241115 | SV Spectrum MRC Central Venous Catheter; SV Spectrum MR Cen... | Spectrum Vascular | 2024 |
Trace the full predicate network for K223648
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.