510(k) K061661
K061661 is an FDA 510(k) premarket notification submitted by Advanced Infusion, Inc. for the device "STA CATH ATTACHABLE INFISION CATHETER, MODEL STA20". The FDA issued a decision of Substantially Equivalent on October 18, 2006. The device falls under product code MEB (Pump, Infusion, Elastomeric), a Class II device regulated under 21 CFR 880.5725. Advanced Infusion, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 18, 2006
- Date Received
- June 13, 2006
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pump, Infusion, Elastomeric
- Device Class
- Class II
- Regulation Number
- 880.5725
- Review Panel
- HO
- Submission Type