myMerlin(TM) Mobile Application Model APP1001— 510(k) K173232
Substantially EquivalentSt Jude Medical
FDA 510(k) clearance K173232 for myMerlin(TM) Mobile Application Model APP1001, Substantially Equivalent on 2017-11-02. Applicant: St Jude Medical. Device class: 2.
Clearance details
- Applicant
- St Jude Medical
- Product code
- Code MXC
- Device class
- Class 2
- Regulation
- 21 CFR 870.2800
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Sylmar, CA, US
Recent devices under product code MXC
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- K172396 — EnSite Velocity Cardiac Mapping System v5.2
- K160210 — EnSite Precision Cardiac Mapping System v2.0
- K160218 — AutoMark Module
- K160335 — Advisor FL 15mm 12 Pole 333 Uni D, Advisor FL 20mm 12 Pole 555 Uni D, Advisor FL 15mm 12 Pole 333 Bi D, Advisor FL 20mm 12 Pole 555 Bi D
Adverse events under product code MXC
product code MXC- Death
- 4
- Injury
- 758
- Malfunction
- 5,066
- Total
- 5,828
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.