Corvocet Coaxial Introducer— 510(k) K151373
Substantially EquivalentMerit Medical Systems, Inc.
FDA 510(k) clearance K151373 for Corvocet Coaxial Introducer, Substantially Equivalent on 2015-08-07. Applicant: Merit Medical Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Merit Medical Systems, Inc.
- Product code
- Code FCG
- Device class
- Class 2
- Regulation
- 21 CFR 876.1075
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- South Jordan, UT, US
Recent devices under product code FCG
view allMore clearances from Merit Medical Systems, Inc.
view allAdverse events under product code FCG
product code FCG- Death
- 13
- Injury
- 576
- Malfunction
- 1,966
- Total
- 2,555
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 K151373
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 K151373.
Data sourced from openFDA. This site is unofficial and independent of the FDA.