Cleared Traditional

K871850 - TELEFLEX STEERABLE GUIDEWIRE

K871850 is an FDA 510(k) clearance for TELEFLEX STEERABLE 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 260-day FDA review.

K871850 · Teleflexmedical, Inc. · Cardiovascular device
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Jan 1988
Decision
260d
Days
Class 2
Risk

K871850 is an FDA 510(k) clearance for the TELEFLEX STEERABLE 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 January 27, 1988 after a review of 260 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 - K871850

510(k) Number K871850 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 1987
Decision Date January 27, 1988
Days to Decision 260 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
135d slower than avg
Panel avg: 125d · This submission: 260d
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 K871850.
CORDIS STEERABLE GUIDEWIRE
K873403 · Cordis Corp. · Mar 1988
TORAY SUPERSELECTIVE GUIDEWIRES, ADDITIONAL TYPES
K874542 · Toray Industries (America), Inc. · Mar 1988
ACS 0.025-IN HI-TORQ MODIF J/STAND TELESC GUIDEWIR
K874776 · Advanced Cardiovascular Systems, Inc. · Feb 1988
STUBBIE STEERABLE GUIDEWIRE
K873543 · Target Therapeutics · Dec 1987
OLYMPUS PF-25 ULTRATHIN ANGIOSCOPE
K871517 · Olympus Corp. · Nov 1987
LAKE REGION VARIABLE STIFFNESS GUIDEWIRE (VSGW)
K871882 · Lake Region Mfg., Inc. · Sep 1987