CONTINUOUS FLUSH DEVICE/FDI— 510(k) K820202
Substantially EquivalentLinton Biomed Corp.
FDA 510(k) clearance K820202 for CONTINUOUS FLUSH DEVICE/FDI, Substantially Equivalent on 1982-02-12. Applicant: Linton Biomed Corp.. Device class: 2.
Clearance details
- Applicant
- Linton Biomed Corp.
- Product code
- Code DRS
- Device class
- Class 2
- Regulation
- 21 CFR 870.2850
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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- K163172 — HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer Kit
More clearances from Linton Biomed Corp.
view allAdverse events under product code DRS
product code DRS- Death
- 8
- Malfunction
- 776
- Total
- 784
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.