510(k) K042246
K042246 is an FDA 510(k) premarket notification submitted by Advanced Infusion, Inc. for the device "MULTI-DRIP INFUSION CATHETER". The FDA issued a decision of Substantially Equivalent on August 31, 2004. 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
- August 31, 2004
- Date Received
- August 19, 2004
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Pump, Infusion, Elastomeric
- Device Class
- Class II
- Regulation Number
- 880.5725
- Review Panel
- HO
- Submission Type