UNIPOLAR TEMPORARY MYOCARDIAL PACING WIRE MODEL 6494— 510(k) K954809
Substantially EquivalentMedtronic Vascular
FDA 510(k) clearance K954809 for UNIPOLAR TEMPORARY MYOCARDIAL PACING WIRE MODEL 6494, Substantially Equivalent on 1995-12-13. Applicant: Medtronic Vascular. Device class: 2.
Clearance details
- Applicant
- Medtronic Vascular
- Product code
- Code LDF
- Device class
- Class 2
- Regulation
- 21 CFR 870.3680
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Minneapolis, MN, US
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- K220773 — Everest 20 Inflation Device and 3-way Stopcock (AC2200) +3 more
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Adverse events under product code LDF
product code LDF- Death
- 19
- Injury
- 188
- Malfunction
- 694
- Other
- 1
- Total
- 902
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.