510(k) K033858
K033858 is an FDA 510(k) premarket notification submitted by European Custom Manufacturing BV for the device "TEMPORARY BIPOLAR MYOCARDIAL PACING WIRE". The FDA issued a decision of Substantially Equivalent on July 12, 2004. The device falls under product code LDF (Electrode, Pacemaker, Temporary), a Class II device regulated under 21 CFR 870.3680. European Custom Manufacturing BV has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 12, 2004
- Date Received
- December 11, 2003
- 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