MERIT MICROCATHETER— 510(k) K082613
Substantially EquivalentMerit Medical Systems, Inc.
FDA 510(k) clearance K082613 for MERIT MICROCATHETER, Substantially Equivalent on 2008-12-30. 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
- Traditional
- 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 K082613
K-number listed on FDA's recall record- Z-0162-2015 — Merit Maestro Microcatheter, 2.4F 130cm Straight, REF28MC24130ST, Rx Only, Non-pyrogenic Sterile if package is unopened or undamaged.
- Z-0614-2014 — Catheter, Continuous Flush The Merit Microcatheter is intended for general intravascular use, including peripheral and coronary vasculature. Once the subselective region has been accessed, the microcatheter can be used for the controlled and selective infusion of diagnostic, embolic or therapeutic materials into vessels.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K082613.
Data sourced from openFDA. This site is unofficial and independent of the FDA.