510(k) K801968
K801968 is an FDA 510(k) premarket notification submitted by Medical Components, Inc. for the device "HEMOCATH I KIDNEY DIALYSIS CATHETER". The FDA issued a decision of Substantially Equivalent on September 26, 1980. The device falls under product code LBW (Set, Dialysis, Single Needle (Co-Axial Flow)), a Class II device regulated under 21 CFR 876.5540. Medical Components, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 26, 1980
- Date Received
- August 19, 1980
- 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