DeviceClearance

VOYAGER NC CORONARY DILATATION CATHETER AND NC TREK RX CORONARY DILATATION CATHETER— 510(k) K103153

Substantially Equivalent

Abbott Vascular-Cardiac Therapies

FDA 510(k) clearance K103153 for VOYAGER NC CORONARY DILATATION CATHETER AND NC TREK RX CORONARY DILATATION CATHETER, Substantially Equivalent on 2010-12-30. Applicant: Abbott Vascular-Cardiac Therapies. Device class: 2.

Clearance details

Applicant
Abbott Vascular-Cardiac Therapies
Product code
Code LOX
Device class
Class 2
Regulation
21 CFR 870.5100
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Temecula, CA, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code LOX

product code LOX
Death
190
Injury
1,498
Malfunction
9,670
Total
11,358

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 K103153

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 K103153.

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