RTM 36-05, 60-05, RTD 36-05, 60-05 RADIO. LEADWIRE— 510(k) K901780
Substantially EquivalentMedtronic Vascular
FDA 510(k) clearance K901780 for RTM 36-05, 60-05, RTD 36-05, 60-05 RADIO. LEADWIRE, Substantially Equivalent on 1990-10-09. Applicant: Medtronic Vascular. Device class: 2.
Clearance details
- Applicant
- Medtronic Vascular
- Product code
- Code DSA
- Device class
- Class 2
- Regulation
- 21 CFR 870.2900
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Haverhill, MA, US
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Adverse events under product code DSA
product code DSA- Death
- 2
- Total
- 2
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.