Cleared Traditional

K850677 - TELEFLEX GUIDEWIRE

K850677 is an FDA 510(k) clearance for TELEFLEX GUIDEWIRE, manufactured by Teleflexmedical, Inc.. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Traditional 510(k) pathway after a 208-day FDA review.

K850677 · Teleflexmedical, Inc. · Cardiovascular device
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Sep 1985
Decision
208d
Days
Class 2
Risk

K850677 is an FDA 510(k) clearance for the TELEFLEX GUIDEWIRE. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Teleflexmedical, Inc. (Jeffrey, US). The FDA issued a Cleared decision on September 17, 1985 after a review of 208 days - an extended review cycle.

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 Teleflexmedical, Inc. devices

FDA 510(k) Submission Details - K850677

510(k) Number K850677 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 1985
Decision Date September 17, 1985
Days to Decision 208 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
83d slower than avg
Panel avg: 125d · This submission: 208d
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 681
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K850677.
PERCUTANEOUS GUIDEWIRE PLACEMENT SYRINGE 50505
K855089 · Dlp, Inc. · Feb 1986
ELECATH PERCUTANEOUS LEFT ATRIAL CANNULATION SET
K854511 · Electro-Catheter Corp. · Feb 1986
GUIDE WIRE
K853999 · Target Therapeutics · Nov 1985
WHOLEY HI-TORQUE GUIDE WIRES
K852354 · Advanced Cardiovascular Systems, Inc. · Jul 1985
GUIDE, WIRE, ANGIOGRAPHIC
K850827 · Lake Region Mfg., Inc. · Jun 1985
WIRE, GUIDE - MODIFICATION
K850828 · Lake Region Mfg., Inc. · Jun 1985