DeviceClearance

TRUE DILATATION PERCUTANEOUS TRANSLUMINAL VALVULOPLASTY CATHETER, 20MM X 4.5CM, TRUE DILATATION PERCUTANEOUS TRANSLUMINA— 510(k) K121083

Substantially Equivalent

Loma Vista Medical

FDA 510(k) clearance K121083 for TRUE DILATATION PERCUTANEOUS TRANSLUMINAL VALVULOPLASTY CATHETER, 20MM X 4.5CM, TRUE DILATATION PERCUTANEOUS TRANSLUMINA, Substantially Equivalent on 2012-10-11. Applicant: Loma Vista Medical. Device class: 2.

Clearance details

Applicant
Loma Vista Medical
Product code
Code OZT
Device class
Class 2
Regulation
21 CFR 870.1255
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Sunnyvale, CA, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code OZT

view all

Adverse events under product code OZT

product code OZT
Death
20
Other
2
Total
22

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 K121083

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 K121083.

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