Cleared Traditional

SPECTRA GUIDEWIRE INTRODUCER NEEDLE (K082580) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

Device Classification

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 272
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K082580.
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PINNACLE ROII INTRODUCER SHEATH
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PRELUDE SHORT SHEATH INTRODUCER
K082063 · Merit Medical Systems, Inc. · Oct 2008
GLIDESHEATH
K082644 · Terumo Medical Corp. · Sep 2008