MEDTRONIC MODEL 5407S, 5807S & 5410S SURG CABLES— 510(k) K914460
Substantially EquivalentMedtronic Vascular
FDA 510(k) clearance K914460 for MEDTRONIC MODEL 5407S, 5807S & 5410S SURG CABLES, Substantially Equivalent on 1991-11-22. Applicant: Medtronic Vascular. Device class: 2.
Clearance details
- Applicant
- Medtronic Vascular
- Product code
- Code DRF
- Device class
- Class 2
- Regulation
- 21 CFR 870.1220
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Minneapolis, MN, US
Recent devices under product code DRF
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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 DRF
product code DRF- Death
- 127
- Injury
- 1,676
- Malfunction
- 2,003
- Other
- 1
- Total
- 3,807
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.