K223648 is an FDA 510(k) clearance for the Cook® Spectrum® 2 MRC Central Venous Catheter. This device is classified as a Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (Class II - Special Controls, product code FOZ).
Submitted by Cook Advanced Technologies (Lafeyette, US). The FDA issued a Cleared decision on February 3, 2023, 59 days after receiving the submission on December 6, 2022.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5200.
| 510(k) Number | K223648 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 06, 2022 |
| Decision Date | February 03, 2023 |
| Days to Decision | 59 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FOZ - Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5200 |