510(k) K173665
K173665 is an FDA 510(k) premarket notification submitted by Amsino International, Inc. for the device "AMSafe Sure-Lok Needle-Free Connector". The FDA issued a decision of Substantially Equivalent on September 5, 2018. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Amsino International, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 5, 2018
- Date Received
- November 29, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Set, Administration, Intravascular
- Device Class
- Class II
- Regulation Number
- 880.5440
- Review Panel
- HO
- Submission Type