Cleared Traditional

K241784 - Arrow Nitinol Wire

K241784 is the FDA 510(k) clearance for Arrow Nitinol Wire by Teleflex Medical. It is a Class 2 Cardiovascular device (product code DQX) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K241784 · Teleflex Medical · Cardiovascular device
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Sep 2024
Decision
90d
Days
Class 2
Risk

K241784 is an FDA 510(k) clearance for the Arrow® Nitinol Wire. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Teleflex Medical (Morrisville, US). The FDA issued a Cleared decision on September 18, 2024 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1330 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Teleflex Medical devices

Submission Details

510(k) Number K241784 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 2024
Decision Date September 18, 2024
Days to Decision 90 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 125d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQX Wire, Guide, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1330
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DQX Wire, Guide, Catheter

All 499
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