Cleared Traditional

K220075 - Spartan Center Wire

K220075 is an FDA 510(k) clearance for Spartan Center Wire, manufactured by Spartan Micro, Inc.. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K220075 · Spartan Micro, Inc. · Cardiovascular device
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Apr 2022
Decision
99d
Days
Class 2
Risk

K220075 is an FDA 510(k) clearance for the Spartan Center Wire. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Spartan Micro, Inc. (Costa Mesa, US). The FDA issued a Cleared decision on April 19, 2022 after a review of 99 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 Spartan Micro, Inc. devices

FDA 510(k) Submission Details - K220075

510(k) Number K220075 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 2022
Decision Date April 19, 2022
Days to Decision 99 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
26d faster than avg
Panel avg: 125d · This submission: 99d
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 541
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