510(k) K070163
K070163 is an FDA 510(k) premarket notification submitted by Baxa Corp. for the device "SWABBABLE CAP, MODEL 60205". The FDA issued a decision of Substantially Equivalent on August 3, 2007. The device falls under product code ODI (Administration Set Docking Station), a Class II device regulated under 21 CFR 880.5440. Baxa Corp. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 3, 2007
- Date Received
- January 17, 2007
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Administration Set Docking Station
- Device Class
- Class II
- Regulation Number
- 880.5440
- Review Panel
- HO
- Submission Type
Temporary closing IV administration set. Temporary aseptic closure of the male Luer connector of the IV tubing in between uses for the life of the administration set.