510(k) K864507
K864507 is an FDA 510(k) premarket notification submitted by Spectramed, Inc. for the device "V-PACE(TM) TRANSLUMINAL VENTRICULAR/ MODEL SP5540". The FDA issued a decision of Substantially Equivalent on March 6, 1987. The device falls under product code LDF (Electrode, Pacemaker, Temporary), a Class II device regulated under 21 CFR 870.3680. Spectramed, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 6, 1987
- Date Received
- November 14, 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