THERMACYL BLOOD/FLUID WARMER— 510(k) K953741
Substantially EquivalentBaxter Healthcare Corp
FDA 510(k) clearance K953741 for THERMACYL BLOOD/FLUID WARMER, Substantially Equivalent on 1996-06-26. Applicant: Baxter Healthcare Corp. Device class: 2.
Clearance details
- Applicant
- Baxter Healthcare Corp
- Product code
- Code BSB
- Device class
- Class 2
- Regulation
- 21 CFR 864.9205
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Round Lake, IL, US
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Adverse events under product code BSB
product code BSB- Death
- 5
- Malfunction
- 1,778
- Total
- 1,783
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.