510(k) K951949
K951949 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "CLEAR HUB SPINAL NEEDLE, 18, 20, 22, 25 GA.". The FDA issued a decision of Substantially Equivalent on Aug 11, 1995. The device falls under product code BSP (Needle, Conduction, Anesthetic (W/Wo Introducer)), a Class II device regulated under 21 CFR 868.5150. Baxter Healthcare Corp has 507 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 11, 1995
- Date Received
- Apr 26, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Needle, Conduction, Anesthetic (W/Wo Introducer)
- Device Class
- Class II
- Regulation Number
- 868.5150
- Review Panel
- AN
- Submission Type
- 510(k)