DeviceClearance

BARDEX ALL-SILICONE, BARDEX LUBRI-SIL, AND BARDEX LUBRI-SIL I.C. TEMPERATURE-SENSING FOLEY CATHETERS— 510(k) K070582

Substantially Equivalent

C.R. Bard, Inc.

FDA 510(k) clearance K070582 for BARDEX ALL-SILICONE, BARDEX LUBRI-SIL, AND BARDEX LUBRI-SIL I.C. TEMPERATURE-SENSING FOLEY CATHETERS, Substantially Equivalent on 2007-12-07. Applicant: C.R. Bard, Inc.. Device class: 2.

Clearance details

Applicant
C.R. Bard, Inc.
Product code
Code EZL
Device class
Class 2
Regulation
21 CFR 876.5130
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Covington, GA, US
Download summary PDFView on FDA.gov ↗

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More clearances from C.R. Bard, Inc.

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Adverse events under product code EZL

product code EZL
Death
6
Injury
796
Malfunction
4,989
Other
1
Total
5,792

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 K070582

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K070582.

Data sourced from openFDA. This site is unofficial and independent of the FDA.