510(k) K890988
K890988 is an FDA 510(k) premarket notification submitted by Pace Medical for the device "MODEL 3110 HEART WIRE & 3110P PEDIATRIC HEART WIRE". The FDA issued a decision of Substantially Equivalent on August 25, 1989. The device falls under product code LDF (Electrode, Pacemaker, Temporary), a Class II device regulated under 21 CFR 870.3680. Pace Medical has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 25, 1989
- Date Received
- February 27, 1989
- 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