510(k) K802259
K802259 is an FDA 510(k) premarket notification submitted by Stanco Medical, Inc. for the device "TRANSVENOUS PACEMAKER ELECTRODE KIT". The FDA issued a decision of Substantially Equivalent on October 23, 1980. The device falls under product code LDF (Electrode, Pacemaker, Temporary), a Class II device regulated under 21 CFR 870.3680. Stanco Medical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 23, 1980
- Date Received
- September 16, 1980
- 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