Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220) +2 more— 510(k) K253514
Substantially EquivalentC.R. Bard, Inc.
FDA 510(k) clearance K253514 for Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220) +2 more, Substantially Equivalent on 2026-07-10. Applicant: C.R. Bard, Inc.. Device class: 2.
Clearance details
- Device name as filed
- Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore Esophageal-Nasogastric Tube - 20 French (0092100); Blakemore Esophageal-Nasogastric Tube - 16 French (0092300)
- Applicant
- C.R. Bard, Inc.
- Product code
- Code KNT
- Device class
- Class 2
- Regulation
- 21 CFR 876.5980
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Covington, GA, US
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Adverse events under product code KNT
product code KNT- Death
- 192
- Injury
- 6,034
- Malfunction
- 4,049
- Other
- 1
- Total
- 10,276
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.