510(k) K023140
K023140 is an FDA 510(k) premarket notification submitted by Epimed International, Inc. for the device "VERSA-KATH EPIDURAL CATHETER, MODEL 156-2124". The FDA issued a decision of Substantially Equivalent on August 15, 2003. The device falls under product code BSO (Catheter, Conduction, Anesthetic), a Class II device regulated under 21 CFR 868.5120. Epimed International, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 15, 2003
- Date Received
- September 20, 2002
- 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