510(k) K897194
K897194 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "PHARMASEAL EPIDURAL CATHETER & CONTINUOUS EPIDURAL". The FDA issued a decision of Substantially Equivalent on Jun 18, 1990. The device falls under product code BSO (Catheter, Conduction, Anesthetic), a Class II device regulated under 21 CFR 868.5120. Baxter Healthcare Corp has 507 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 18, 1990
- Date Received
- Dec 29, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Catheter, Conduction, Anesthetic
- Device Class
- Class II
- Regulation Number
- 868.5120
- Review Panel
- AN
- Submission Type
- 510(k)