510(k) K832850
K832850 is an FDA 510(k) premarket notification submitted by Electro-Catheter Corp. for the device "ELECATH PACEWEDGE DUAL PRESS. BIPOLAR". The FDA issued a decision of Substantially Equivalent on October 19, 1983. 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
- October 19, 1983
- Date Received
- August 22, 1983
- 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