Streamline 6495 Bipolar Temporary Myocardial Pacing Lead— 510(k) K161249
Substantially EquivalentMedtronic
FDA 510(k) clearance K161249 for Streamline 6495 Bipolar Temporary Myocardial Pacing Lead, Substantially Equivalent on 2016-08-19. Applicant: Medtronic. Device class: 2.
Clearance details
- Applicant
- Medtronic
- 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
- Special
- Location
- Santa Ana, CA, US
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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.