510(k) K840109
K840109 is an FDA 510(k) premarket notification submitted by Electro-Catheter Corp. for the device "ELECATH HEPARIN COATED TEMP. PACING". The FDA issued a decision of Substantially Equivalent on February 4, 1984. The device falls under product code LDF (Electrode, Pacemaker, Temporary), a Class II device regulated under 21 CFR 870.3680. Electro-Catheter Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 4, 1984
- Date Received
- January 10, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrode, Pacemaker, Temporary
- Device Class
- Class II
- Regulation Number
- 870.3680
- Review Panel
- CV
- Submission Type