Cleared Traditional

K253667 - Accoat Guide Wire

K253667 is an FDA 510(k) clearance for Accoat Guide Wire, manufactured by Sp Medical A/S. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Traditional 510(k) pathway after a 235-day FDA review.

K253667 · Sp Medical A/S · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2026
Decision
235d
Days
Class 2
Risk

K253667 is an FDA 510(k) clearance for the Accoat Guide Wire. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Sp Medical A/S (Karise, DK). The FDA issued a Cleared decision on July 14, 2026 after a review of 235 days - an extended review cycle.

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 Sp Medical A/S devices

FDA 510(k) Submission Details - K253667

510(k) Number K253667 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2025
Decision Date July 14, 2026
Days to Decision 235 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
110d slower than avg
Panel avg: 125d · This submission: 235d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 542
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K253667.
InQwire Amplatz Guide Wire
K254137 · Merit Medical Ireland, Ltd. · May 2026
FMD Peripheral Guide Wire F-14 Flex 6
K260544 · FMD Co., Ltd. · Mar 2026
Enroute 0.014'' Transcarotid Guidewire
K253746 · Lake Region Medical · Mar 2026
EmeryGlide™ (EG18008901)
K253262 · Nano4imaging GmbH · Mar 2026
Splashwire Hydrophilic Guide Wire (MSWSTD35150J3)
K253847 · Merit Medical Ireland, Ltd. · Jan 2026
InQwire Super Stiff Guide Wire (IQSS32180J3)
K251385 · Merit Medical Ireland, Ltd. · Jan 2026