Cleared Special

K240460 - FMD Peripheral Guide Wire F-18 Flex 400 (CSU415400259)

K240460 is an FDA 510(k) clearance for FMD Peripheral Guide Wire F-18 Flex 400..., manufactured by FMD Co., Ltd.. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Special 510(k) pathway after a 118-day FDA review.

K240460 · FMD Co., Ltd. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2024
Decision
118d
Days
Class 2
Risk

K240460 is an FDA 510(k) clearance for the FMD Peripheral Guide Wire F-18 Flex 400 (CSU415400259). Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by FMD Co., Ltd. (Shibuya-Ku, JP). The FDA issued a Cleared decision on June 13, 2024 after a review of 118 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K240460

510(k) Number K240460 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 2024
Decision Date June 13, 2024
Days to Decision 118 days
Submission Type Special
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
7d faster than avg
Panel avg: 125d · This submission: 118d
Pathway characteristics
Modification to existing cleared device.

DQX Device Classification - Class 2, Special Controls

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 768
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K240460 · FMD Peripheral Guide Wire F-18 Flex 400 (CSU415400259)
Download PDF FDA Summary FMD Co., Ltd.