510(k) K050906
K050906 is an FDA 510(k) premarket notification submitted by Vitalcare Group, Inc. for the device "VITALCARE I.V. ADMINISTRATION SET". The FDA issued a decision of Substantially Equivalent on Aug 23, 2005. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Vitalcare Group, Inc. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 23, 2005
- Date Received
- Apr 11, 2005
- 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