510(k) K033963
K033963 is an FDA 510(k) premarket notification submitted by Ep Medsystems, Inc. for the device "EP DEFLECTABLE CATHETERS". The FDA issued a decision of Substantially Equivalent on April 15, 2004. The device falls under product code DRF (Catheter, Electrode Recording, Or Probe, Electrode Recording), a Class II device regulated under 21 CFR 870.1220. Ep Medsystems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 15, 2004
- Date Received
- December 22, 2003
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Electrode Recording, Or Probe, Electrode Recording
- Device Class
- Class II
- Regulation Number
- 870.1220
- Review Panel
- CV
- Submission Type