AngioVac Circuit— 510(k) K142607
Substantially EquivalentAngiodynamics
FDA 510(k) clearance K142607 for AngioVac Circuit, Substantially Equivalent on 2014-12-11. Applicant: Angiodynamics. Device class: 2.
Clearance details
- Applicant
- Angiodynamics
- Product code
- Code DWE
- Device class
- Class 2
- Regulation
- 21 CFR 870.4390
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Marlborough, MA, US
Recent devices under product code DWE
view allMore clearances from Angiodynamics
view allAdverse events under product code DWE
product code DWE- Death
- 9
- Malfunction
- 754
- Total
- 763
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 K142607
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 K142607.
Data sourced from openFDA. This site is unofficial and independent of the FDA.