GUNHTER TULIP VENA CAVA MREYE FILTER AND RETRIEVAL SET— 510(k) K032426
Substantially EquivalentCook, Inc.
FDA 510(k) clearance K032426 for GUNHTER TULIP VENA CAVA MREYE FILTER AND RETRIEVAL SET, Substantially Equivalent on 2003-10-31. Applicant: Cook, Inc.. Device class: 2.
Clearance details
- Applicant
- Cook, Inc.
- 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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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.