510(k) K860155
K860155 is an FDA 510(k) premarket notification submitted by Medical Components, Inc. for the device "PERITONEAL LAVAGE CATH PLC-8,SET PLS-8, KIT PLK-8". The FDA issued a decision of Substantially Equivalent (with conditions) on February 14, 1986. The device falls under product code FKO (Catheter, Peritoneal Dialysis, Single Use), a Class II device regulated under 21 CFR 876.5630. Medical Components, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESD (Substantially Equivalent (with conditions))
- Decision Date
- February 14, 1986
- Date Received
- January 16, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Peritoneal Dialysis, Single Use
- Device Class
- Class II
- Regulation Number
- 876.5630
- Review Panel
- GU
- Submission Type