DeviceClearance

Endo Vive 3S Low Profile Balloon Kit, Endo Vive 3S Bolus Extension Sets, Endo Vive 3S Continuous Extension Sets, Endo Vive 3S Medication Extension Set— 510(k) K142297

Substantially Equivalent

Xeridiem (Formerly Mri)

FDA 510(k) clearance K142297 for Endo Vive 3S Low Profile Balloon Kit, Endo Vive 3S Bolus Extension Sets, Endo Vive 3S Continuous Extension Sets, Endo Vive 3S Medication Extension Set, Substantially Equivalent on 2015-01-08. Applicant: Xeridiem (Formerly Mri). Device class: 2.

Clearance details

Applicant
Xeridiem (Formerly Mri)
Product code
Code PIF
Device class
Class 2
Regulation
21 CFR 876.5980
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Tucson, AZ, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code PIF

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More clearances from Xeridiem (Formerly Mri)

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Adverse events under product code PIF

product code PIF
Death
13
Injury
122
Other
1
Total
136

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 K142297

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 K142297.

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