Cleared Traditional

K082580 - SPECTRA GUIDEWIRE INTRODUCER NEEDLE

K082580 is an FDA 510(k) clearance for SPECTRA GUIDEWIRE INTRODUCER NEEDLE, manufactured by Spectra Medical Devices, Inc.. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K082580 · Spectra Medical Devices, Inc. · Cardiovascular device
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Dec 2008
Decision
94d
Days
Class 2
Risk

K082580 is an FDA 510(k) clearance for the SPECTRA GUIDEWIRE INTRODUCER NEEDLE. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Spectra Medical Devices, Inc. (Wilmington, US). The FDA issued a Cleared decision on December 8, 2008 after a review of 94 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1340 - 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 Spectra Medical Devices, Inc. devices

FDA 510(k) Submission Details - K082580

510(k) Number K082580 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 2008
Decision Date December 08, 2008
Days to Decision 94 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
31d faster than avg
Panel avg: 125d · This submission: 94d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DYB Device Classification - Class 2, Special Controls

Product Code DYB Introducer, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1340
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 - DYB Introducer, Catheter

All 477
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K082580.
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