510(k) K012926
K012926 is an FDA 510(k) premarket notification submitted by Endocardial Solutions, Inc. for the device "MODIFICATION TO ENSITE 3000 SYSTEM, MODEL EE3000". The FDA issued a decision of SESU on September 28, 2001. The device falls under product code MTD (Catheter, Intracardiac Mapping, High-Density Array), a Class II device regulated under 21 CFR 870.1220. Endocardial Solutions, Inc. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESU ()
- Decision Date
- September 28, 2001
- Date Received
- August 31, 2001
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Intracardiac Mapping, High-Density Array
- Device Class
- Class II
- Regulation Number
- 870.1220
- Review Panel
- CV
- Submission Type