Cleared Special

K033321 - SELECTIVA SB GUIDEWIRE

K033321 is the FDA 510(k) clearance for SELECTIVA SB GUIDEWIRE by Neometrics, Inc.. It is a Class 2 Cardiovascular device (product code DQX) cleared through the Special 510(k) pathway after a 21-day FDA review.

K033321 · Neometrics, Inc. · Cardiovascular device
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Nov 2003
Decision
21d
Days
Class 2
Risk

K033321 is an FDA 510(k) clearance for the SELECTIVA SB GUIDEWIRE. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Neometrics, Inc. (Plymouth, US). The FDA issued a Cleared decision on November 5, 2003 after a review of 21 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1330 - 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 Neometrics, Inc. devices

Submission Details

510(k) Number K033321 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 2003
Decision Date November 05, 2003
Days to Decision 21 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
104d faster than avg
Panel avg: 125d · This submission: 21d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 439
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