MPS2 Myocardial Protection System Console— 510(k) K173716
Substantially EquivalentQuest Medical, Inc.
FDA 510(k) clearance K173716 for MPS2 Myocardial Protection System Console, Substantially Equivalent on 2018-10-01. Applicant: Quest Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Quest Medical, Inc.
- Product code
- Code DTR
- Device class
- Class 2
- Regulation
- 21 CFR 870.4240
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Allen, TX, US
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More clearances from Quest Medical, Inc.
view allAdverse events under product code DTR
product code DTR- Other
- 1
- Total
- 1
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 K173716
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 K173716.
Data sourced from openFDA. This site is unofficial and independent of the FDA.