GORE TIPS Set, GORE TIPS Sheath, GORE TIPS Needle— 510(k) K152913
Substantially EquivalentCreganna Medical Aslo Business AS Cregganna Tactx Medical
FDA 510(k) clearance K152913 for GORE TIPS Set, GORE TIPS Sheath, GORE TIPS Needle, Substantially Equivalent on 2016-07-21. Applicant: Creganna Medical Aslo Business AS Cregganna Tactx Medical. Device class: 2.
Clearance details
- Applicant
- Creganna Medical Aslo Business AS Cregganna Tactx Medical
- Product code
- Code DYB
- Device class
- Class 2
- Regulation
- 21 CFR 870.1340
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Galway, IE
Recent devices under product code DYB
view allMore clearances from Creganna Medical Aslo Business AS Cregganna Tactx Medical
view allAdverse events under product code DYB
product code DYB- Death
- 808
- Injury
- 5,922
- Malfunction
- 16,516
- Other
- 5
- Total
- 23,251
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 →
Recalls naming K152913
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K152913.
Data sourced from openFDA. This site is unofficial and independent of the FDA.