CORDIS TRAPEASE PERMANENT VENA CAVA FILTER AND INTRODUCTION KIT— 510(k) K000062
Substantially EquivalentCordis Corp.
FDA 510(k) clearance K000062 for CORDIS TRAPEASE PERMANENT VENA CAVA FILTER AND INTRODUCTION KIT, Substantially Equivalent on 2000-07-07. Applicant: Cordis Corp.. Device class: 2.
Clearance details
- Applicant
- Cordis Corp.
- 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
- Warren, NJ, US
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Adverse 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.