510(k) K860515
K860515 is an FDA 510(k) premarket notification submitted by Quinton, Inc. for the device "DUAL LUMEN NEEDLE (PRODUCT CHANGE)". The FDA issued a decision of Substantially Equivalent on March 4, 1986. The device falls under product code LBW (Set, Dialysis, Single Needle (Co-Axial Flow)), a Class II device regulated under 21 CFR 876.5540. Quinton, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 4, 1986
- Date Received
- February 11, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Set, Dialysis, Single Needle (Co-Axial Flow)
- Device Class
- Class II
- Regulation Number
- 876.5540
- Review Panel
- GU
- Submission Type