BARRIERBAC AND BARRIERBAC S— 510(k) K941536
Substantially EquivalentMallinckrodt Medical
FDA 510(k) clearance K941536 for BARRIERBAC AND BARRIERBAC S, Substantially Equivalent on 1994-04-19. Applicant: Mallinckrodt Medical. Device class: 2.
Clearance details
- Applicant
- Mallinckrodt Medical
- Product code
- Code CAH
- Device class
- Class 2
- Regulation
- 21 CFR 868.5260
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Argyle, NY, US
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Adverse events under product code CAH
product code CAH- Death
- 7
- Total
- 7
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 K941536
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 K941536.
Data sourced from openFDA. This site is unofficial and independent of the FDA.