510(k) K111651
K111651 is an FDA 510(k) premarket notification submitted by Medical Components, Inc. for the device "SPLIT CATH III". The FDA issued a decision of Substantially Equivalent (kit) on December 8, 2011. The device falls under product code MSD (Catheter, Hemodialysis, Implanted), 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
- SESK (Substantially Equivalent (kit))
- Decision Date
- December 8, 2011
- Date Received
- June 13, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Hemodialysis, Implanted
- Device Class
- Class II
- Regulation Number
- 876.5540
- Review Panel
- GU
- Submission Type