510(k) K223648
K223648 is an FDA 510(k) premarket notification submitted by Cook Advanced Technologies for the device "Cook® Spectrum® 2 MRC Central Venous Catheter". The FDA issued a decision of Substantially Equivalent on Feb 3, 2023. The device falls under product code FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days), a Class II device regulated under 21 CFR 880.5200.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 3, 2023
- Date Received
- Dec 6, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- Device Class
- Class II
- Regulation Number
- 880.5200
- Review Panel
- HO
- Submission Type
- 510(k)