510(k) K861409
K861409 is an FDA 510(k) premarket notification submitted by Gyneco, Inc. for the device "SYNCARE TEMPORARY CARDIAC PACING WIRE". The FDA issued a decision of Substantially Equivalent on May 5, 1986. The device falls under product code LDF (Electrode, Pacemaker, Temporary), a Class II device regulated under 21 CFR 870.3680. Gyneco, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 5, 1986
- Date Received
- April 15, 1986
- 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