510(k) K022561
K022561 is an FDA 510(k) premarket notification submitted by C.R. Bard, Inc. for the device "CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000". The FDA issued a decision of Substantially Equivalent on August 23, 2002. The device falls under product code NFK (Kit, Repair, Catheter, Hemodialysis), a Class II device regulated under 21 CFR 876.5540. C.R. Bard, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 23, 2002
- Date Received
- August 2, 2002
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Kit, Repair, Catheter, Hemodialysis
- Device Class
- Class II
- Regulation Number
- 876.5540
- Review Panel
- GU
- Submission Type
Hemodialysis Tray