SOLUTION SET WITH 1.2 MICRON AIR ELIMINATING FILTER— 510(k) K952074
Substantially EquivalentBaxter Healthcare Corp
FDA 510(k) clearance K952074 for SOLUTION SET WITH 1.2 MICRON AIR ELIMINATING FILTER, Substantially Equivalent on 1995-07-27. Applicant: Baxter Healthcare Corp. Device class: 2.
Clearance details
- Applicant
- Baxter Healthcare Corp
- Product code
- Code FPA
- Device class
- Class 2
- Regulation
- 21 CFR 880.5440
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Round Lake, IL, US
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Adverse events under product code FPA
product code FPA- Death
- 95
- Injury
- 14,421
- Malfunction
- 125,815
- Other
- 30
- Total
- 140,361
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 →
Recalls naming K952074
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K952074.
Data sourced from openFDA. This site is unofficial and independent of the FDA.