510(k) K845041
K845041 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "CAPD STAGED CONNECTOR". The FDA issued a decision of Substantially Equivalent on February 21, 1985. The device falls under product code FKO (Catheter, Peritoneal Dialysis, Single Use), a Class II device regulated under 21 CFR 876.5630. Abbott Laboratories has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 21, 1985
- Date Received
- December 28, 1984
- 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