510(k) K022523
K022523 is an FDA 510(k) premarket notification submitted by Baxa Corp. for the device "RAPID-FILL TUBESET, MODEL 90005". The FDA issued a decision of Substantially Equivalent on August 12, 2002. The device falls under product code LHI (Set, I.V. Fluid Transfer), 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 12, 2002
- Date Received
- July 30, 2002
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Set, I.V. Fluid Transfer
- Device Class
- Class II
- Regulation Number
- 880.5440
- Review Panel
- HO
- Submission Type