510(k) K140581
K140581 is an FDA 510(k) premarket notification submitted by Cedic S.R.L. for the device "CEDIC ENTERAL DISTAL END ENFIT TRANSITION CONNECTOR, CEDIC ENTERAL ENFIT TRANSITION CONNECTOR FOR MEDICATION PORT". The FDA issued a decision of Substantially Equivalent on October 17, 2014. The device falls under product code PIO (Enteral Specific Transition Connectors), a Class II device regulated under 21 CFR 876.5980. Cedic S.R.L. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 17, 2014
- Date Received
- March 6, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Enteral Specific Transition Connectors
- Device Class
- Class II
- Regulation Number
- 876.5980
- Review Panel
- GU
- Submission Type
Facilitates enteral specific connections between AAMI/CN3(PS):2014 compliant connectors and non ISO 80369-1 compliant legacy enteral connectors.