510(k) K861390
K861390 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "DEPTH MEASURING NEEDLES/VASCU IMPLANT ACCESS SET". The FDA issued a decision of Substantially Equivalent on Jul 17, 1986. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Baxter Healthcare Corp has 507 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 17, 1986
- Date Received
- Apr 14, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Needle, Hypodermic, Single Lumen
- Device Class
- Class II
- Regulation Number
- 880.5570
- Review Panel
- HO
- Submission Type
- 510(k)