510(k) K121599
K121599 is an FDA 510(k) premarket notification submitted by Fresenius Medical Care-North America for the device "CRIT-LINE CLIP (CLIC)". The FDA issued a decision of Substantially Equivalent on November 9, 2012. The device falls under product code KOC (Accessories, Blood Circuit, Hemodialysis), a Class II device regulated under 21 CFR 876.5820.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 9, 2012
- Date Received
- June 1, 2012
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Accessories, Blood Circuit, Hemodialysis
- Device Class
- Class II
- Regulation Number
- 876.5820
- Review Panel
- GU
- Submission Type