Imperative Care Radial 088 Access System— 510(k) K220807
Substantially EquivalentImperative Care, Inc.
FDA 510(k) clearance K220807 for Imperative Care Radial 088 Access System, Substantially Equivalent on 2022-05-17. Applicant: Imperative Care, Inc.. Device class: 2.
Clearance details
- Applicant
- Imperative Care, Inc.
- Product code
- Code QJP
- Device class
- Class 2
- Regulation
- 21 CFR 870.1250
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Campbell, CA, US
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Adverse events under product code QJP
product code QJP- Death
- 43
- Injury
- 233
- Malfunction
- 1,010
- Total
- 1,286
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.