Anchor Dual Lumen Guidewire Catheter— 510(k) K201076
Substantially EquivalentAqure Medical, Inc.
FDA 510(k) clearance K201076 for Anchor Dual Lumen Guidewire Catheter, Substantially Equivalent on 2020-08-06. Applicant: Aqure Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Aqure Medical, Inc.
- Product code
- Code QJP
- Device class
- Class 2
- Regulation
- 21 CFR 870.1250
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rogers, MN, US
Recent devices under product code QJP
view allAdverse events under product code QJP
product code QJP- Death
- 43
- Injury
- 233
- Malfunction
- 1,010
- Total
- 1,286
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.