DeviceClearance

TRANSRADIAL ARTERY ACCESS DEVICES— 510(k) K112554

Substantially Equivalent

Teleflexmedical, Inc.

FDA 510(k) clearance K112554 for TRANSRADIAL ARTERY ACCESS DEVICES, Substantially Equivalent on 2011-11-18. Applicant: Teleflexmedical, Inc.. Device class: 2.

Clearance details

Applicant
Teleflexmedical, Inc.
Product code
Code DYB
Device class
Class 2
Regulation
21 CFR 870.1340
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Reading, PA, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code DYB

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More clearances from Teleflexmedical, Inc.

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Adverse events under product code DYB

product code DYB
Death
808
Injury
5,922
Malfunction
16,516
Other
5
Total
23,251

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 K112554

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 K112554.

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