510(k) K042105
K042105 is an FDA 510(k) premarket notification submitted by Bard Electrophysiology for the device "CLIPPER DIAGNOSTIC ELECTRODE CATHETER". The FDA issued a decision of Substantially Equivalent on September 23, 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. Bard Electrophysiology has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 23, 2004
- Date Received
- August 4, 2004
- 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