Maestro Microcatheter— 510(k) K172081
Substantially EquivalentMerit Medical Systems, Inc.
FDA 510(k) clearance K172081 for Maestro Microcatheter, Substantially Equivalent on 2017-08-04. Applicant: Merit Medical Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Merit Medical Systems, Inc.
- Product code
- Code KRA
- Device class
- Class 2
- Regulation
- 21 CFR 870.1210
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- South Jordan, UT, US
Recent devices under product code KRA
view allMore clearances from Merit Medical Systems, Inc.
view allAdverse events under product code KRA
product code KRA- Death
- 234
- Injury
- 1,029
- Malfunction
- 3,012
- Other
- 2
- Total
- 4,277
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 K172081
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 K172081.
Data sourced from openFDA. This site is unofficial and independent of the FDA.