BARD BALLOON DILATION KIT WITH TRIFUNNEL GASTROSTOMY TUBE— 510(k) K063118

Substantially Equivalent

C.R. Bard, Inc.

FDA 510(k) clearance K063118 for BARD BALLOON DILATION KIT WITH TRIFUNNEL GASTROSTOMY TUBE, Substantially Equivalent on 2007-02-13. Applicant: C.R. Bard, Inc..

Clearance details

Applicant: C.R. Bard, Inc.
Product code: Code KNT
Advisory panel: Gastroenterology, Urology
Date received: 2006-10-11
Decision date: 2007-02-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, 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, 2020-01-01 through 2026-04-23. 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.