Option (TM) ELITE Vena Cava Filter 100cm System— 510(k) K143405
Substantially EquivalentRex Medical, L.P.
FDA 510(k) clearance K143405 for Option (TM) ELITE Vena Cava Filter 100cm System, Substantially Equivalent on 2015-04-16. Applicant: Rex Medical, L.P.. Device class: 2.
Clearance details
- Applicant
- Rex Medical, L.P.
- Product code
- Code DTK
- Device class
- Class 2
- Regulation
- 21 CFR 870.3375
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Conshohocken, PA, US
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More clearances from Rex Medical, L.P.
view allAdverse events under product code DTK
product code DTK- Death
- 208
- Injury
- 11,286
- Malfunction
- 3,002
- Total
- 14,496
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.