510(k) K113487
K113487 is an FDA 510(k) premarket notification submitted by Medical Components, Inc. for the device "HEMO-CATH 10F, HEMO-CATH 12.5F". The FDA issued a decision of Substantially Equivalent (kit) on March 9, 2012. 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
- March 9, 2012
- Date Received
- November 23, 2011
- Clearance Type
- Special
- 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