510(k) K811463
K811463 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "AUTO-SYRINGE MICRO VOLUME EXTENSION SET". The FDA issued a decision of Substantially Equivalent on Jun 12, 1981. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Baxter Healthcare Corp has 507 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 12, 1981
- Date Received
- May 26, 1981
- 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
- 510(k)