Cleared Traditional

K884183 - BURRON TEFLON-COATED GUIDEWIRE

K884183 is an FDA 510(k) clearance for BURRON TEFLON-COATED GUIDEWIRE, manufactured by Burron Medical, Inc.. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Traditional 510(k) pathway after a 303-day FDA review.

K884183 · Burron Medical, Inc. · Cardiovascular device
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Aug 1989
Decision
303d
Days
Class 2
Risk

K884183 is an FDA 510(k) clearance for the BURRON TEFLON-COATED GUIDEWIRE. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Burron Medical, Inc. (Bethlehem, US). The FDA issued a Cleared decision on August 3, 1989 after a review of 303 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Burron Medical, Inc. devices

FDA 510(k) Submission Details - K884183

510(k) Number K884183 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 1988
Decision Date August 03, 1989
Days to Decision 303 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
178d slower than avg
Panel avg: 125d · This submission: 303d
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 700
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K884183.
DATASCOPE INTERLOCK GUIDE WIRE EXTENSION
K894318 · Datascope Corp. · Oct 1989
FLEXMEDICS GUIDEWIRE
K893626 · Flexmedics · Sep 1989
USCI PROBE LINX EXTENSION WIRE
K890404 · C.R. Bard, Inc. · Aug 1989
USCI GREY/BLACK GUIDE WIRE
K890505 · C.R. Bard, Inc. · Jun 1989
GUIDE WIRE INTRODUCER
K890807 · Datascope Corp. · Jun 1989
INTERVENTIONAL PRODUCTS - GUIDE WIRES
K890207 · E-Z-Em, Inc. · May 1989