MONITORING, PRESSURE KIT— 510(k) K781680
Substantially EquivalentPharmaseal Div., Baxter Healthcare Corp.
FDA 510(k) clearance K781680 for MONITORING, PRESSURE KIT, Substantially Equivalent on 1978-10-06. Applicant: Pharmaseal Div., Baxter Healthcare Corp.. Device class: 2.
Clearance details
- Applicant
- Pharmaseal Div., Baxter Healthcare 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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- K172458 — HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer Kit
- K163172 — HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer Kit
More clearances from Pharmaseal Div., Baxter Healthcare 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.