510(k) K180054
K180054 is an FDA 510(k) premarket notification submitted by Cook Incorporated for the device "Royal Flush Plus High-Flow Catheter". The FDA issued a decision of Substantially Equivalent on Oct 5, 2018. The device falls under product code DQO (Catheter, Intravascular, Diagnostic), a Class II device regulated under 21 CFR 870.1200. Cook Incorporated has 174 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 5, 2018
- Date Received
- Jan 8, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Intravascular, Diagnostic
- Device Class
- Class II
- Regulation Number
- 870.1200
- Review Panel
- CV
- Submission Type
- 510(k)