Cleared Traditional

K882804 - 0.014 PERIPHERAL GUIDE WIRE

K882804 is an FDA 510(k) clearance for 0.014 PERIPHERAL GUIDE WIRE, manufactured by Intensive Technology, Inc.. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K882804 · Intensive Technology, Inc. · Cardiovascular device
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Oct 1988
Decision
113d
Days
Class 2
Risk

K882804 is an FDA 510(k) clearance for the 0.014 PERIPHERAL GUIDE WIRE. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Intensive Technology, Inc. (San Diego, US). The FDA issued a Cleared decision on October 28, 1988 after a review of 113 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 Intensive Technology, Inc. devices

FDA 510(k) Submission Details - K882804

510(k) Number K882804 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 1988
Decision Date October 28, 1988
Days to Decision 113 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 125d · This submission: 113d
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 696
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K882804.
ACS(R) HI-TORQUE GOLD(TM) GUIDE WIRE
K884262 · Advanced Cardiovascular Systems, Inc. · Dec 1988
TARGET THERAPEUTICS SEEKER-16 STEERABLE GUIDEWIRE
K884198 · Target Therapeutics · Dec 1988
CORONARY GUIDE WIRE
K883579 · Datascope Corp. · Nov 1988
TAD INTERMEDIATE & TAD STANDARD GUIDE WIRE
K882928 · Advanced Cardiovascular Systems, Inc. · Sep 1988
ACS DEFLECTABLE TIP GUIDE WIRE W/MICROGLIDE(R)COAT
K882321 · Advanced Cardiovascular Systems, Inc. · Aug 1988
COATING FOR WIRE GUIDE
K880722 · Cook, Inc. · Aug 1988