DeviceClearance

LONG SHEATH OR LS, 70 CM, LONG SHEATH OR LS, 80 CM, LONG SHEATH OR LS, 90 CM— 510(k) K152876

Substantially Equivalent

Tni Manufacturing, Inc.

FDA 510(k) clearance K152876 for LONG SHEATH OR LS, 70 CM, LONG SHEATH OR LS, 80 CM, LONG SHEATH OR LS, 90 CM, Substantially Equivalent on 2016-01-08. Applicant: Tni Manufacturing, Inc.. Device class: 2.

Clearance details

Applicant
Tni Manufacturing, Inc.
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
Traditional
Location
Sunrise, FL, US
Download summary PDFView on FDA.gov ↗

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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 K152876

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 K152876.

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