510(k) K031361
K031361 is an FDA 510(k) premarket notification submitted by Deltec, Inc. for the device "CADD HIGH-VOLUME ADMINISTRATION SETS WITH FLOWSTOP". The FDA issued a decision of Substantially Equivalent on May 23, 2003. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Deltec, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 23, 2003
- Date Received
- April 30, 2003
- Clearance Type
- Special
- 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