QUEST MPS PERFUSION ASSISTED DIRECT CORONARY ARTERY BYPASS (PADCAB)— 510(k) K994274
Substantially EquivalentQuest Medical, Inc.
FDA 510(k) clearance K994274 for QUEST MPS PERFUSION ASSISTED DIRECT CORONARY ARTERY BYPASS (PADCAB), Substantially Equivalent on 2000-05-31. Applicant: Quest Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Quest Medical, Inc.
- Product code
- Code FRN
- Device class
- Class 2
- Regulation
- 21 CFR 880.5725
- Advisory panel
- General Hospital
- 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 FRN
product code FRN- Death
- 540
- Injury
- 6,178
- Malfunction
- 1,464,165
- Other
- 52
- Total
- 1,470,935
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.