Cleared Traditional

K850677 - TELEFLEX GUIDEWIRE

K850677 is the FDA 510(k) clearance for TELEFLEX GUIDEWIRE by Teleflexmedical, Inc.. It is a Class 2 Cardiovascular device (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

Submission Details

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.

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 500
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