510(k) K850324
K850324 is an FDA 510(k) premarket notification submitted by Electro-Catheter Corp. for the device "ELECATH OPEN TIP BIPOLAR PACING CATHETER". The FDA issued a decision of Substantially Equivalent on March 27, 1985. 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
- March 27, 1985
- Date Received
- January 28, 1985
- 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