Progreat— 510(k) K170223
Substantially EquivalentAshitaka Factory of Terumo Corporation
FDA 510(k) clearance K170223 for Progreat, Substantially Equivalent on 2017-07-21. Applicant: Ashitaka Factory of Terumo Corporation. Device class: 2.
Clearance details
- Applicant
- Ashitaka Factory of Terumo Corporation
- Product code
- Code DQO
- Device class
- Class 2
- Regulation
- 21 CFR 870.1200
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Fujinomiya, JP
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More clearances from Ashitaka Factory of Terumo Corporation
view allAdverse events under product code DQO
product code DQO- Death
- 35
- Injury
- 993
- Malfunction
- 1,772
- Other
- 5
- Total
- 2,805
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.