FETCH 2 ASPIRATION CATHETER MODEL 109400-001— 510(k) K101354
Substantially EquivalentMedrad Interventional/Possis
FDA 510(k) clearance K101354 for FETCH 2 ASPIRATION CATHETER MODEL 109400-001, Substantially Equivalent on 2011-01-21. Applicant: Medrad Interventional/Possis. Device class: 2.
Clearance details
- Applicant
- Medrad Interventional/Possis
- Product code
- Code QEZ
- Device class
- Class 2
- Regulation
- 21 CFR 870.5150
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Minneapolis, MN, US
Recent devices under product code QEZ
view allMore clearances from Medrad Interventional/Possis
view allAdverse events under product code QEZ
product code QEZ- Death
- 24
- Total
- 24
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 K101354
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 K101354.
Data sourced from openFDA. This site is unofficial and independent of the FDA.