Cleared Special

K142565 - Excelsior XT-17 Microcatheter, Excelsior XT-17 Flex Microcatheter, Excelsior XT-17 Pre-Shaped Microcatheter, Excelsior XT-17 Flex Pre-Shaped Microcatheter

K142565 is an FDA 510(k) clearance for Excelsior XT-17 Microcatheter, manufactured by Stryker Neurovascular. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Special 510(k) pathway after a 63-day FDA review.

K142565 · Stryker Neurovascular · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2014
Decision
63d
Days
Class 2
Risk

K142565 is an FDA 510(k) clearance for the Excelsior XT-17 Microcatheter, Excelsior XT-17 Flex Microcatheter, Excelsior .... Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Stryker Neurovascular (Fremont, US). The FDA issued a Cleared decision on November 14, 2014 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Stryker Neurovascular devices

FDA 510(k) Submission Details - K142565

510(k) Number K142565 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 2014
Decision Date November 14, 2014
Days to Decision 63 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
62d faster than avg
Panel avg: 125d · This submission: 63d
Pathway characteristics
Modification to existing cleared device.

DQY Device Classification - Class 2, Special Controls

Product Code DQY Catheter, Percutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
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 - DQY Catheter, Percutaneous

All 780
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