DeviceClearance

TorqVue Low Profile Delivery Catheter— 510(k) K162228

Substantially Equivalent

Aga Medical Corporation (Wholly Owned by St.Jude Medical Cor

FDA 510(k) clearance K162228 for TorqVue Low Profile Delivery Catheter, Substantially Equivalent on 2016-09-09. Applicant: Aga Medical Corporation (Wholly Owned by St.Jude Medical Cor. Device class: 2.

Clearance details

Applicant
Aga Medical Corporation (Wholly Owned by St.Jude Medical Cor
Product code
Code DQY
Device class
Class 2
Regulation
21 CFR 870.1250
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Plymouth, MN, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code DQY

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Adverse events under product code DQY

product code DQY
Death
464
Injury
4,489
Malfunction
13,721
Other
2
Total
18,676

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 K162228

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 K162228.

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