Gianturco-Roehm Birds Nest Vena Cava Filter— 510(k) K161218
Substantially EquivalentCook Incorporated
FDA 510(k) clearance K161218 for Gianturco-Roehm Birds Nest Vena Cava Filter, Substantially Equivalent on 2016-07-22. Applicant: Cook Incorporated. Device class: 2.
Clearance details
- Applicant
- Cook Incorporated
- 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
- Bloomington, IN, US
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More clearances from Cook Incorporated
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.