Cleared Traditional

K884647 - USCI ADJUSTABLE TIP GUIDE WIRE

K884647 is the FDA 510(k) clearance for USCI ADJUSTABLE TIP GUIDE WIRE by C.R. Bard, Inc.. It is a Class 2 Cardiovascular device (product code DQX) cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K884647 · C.R. Bard, Inc. · Cardiovascular device
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Jan 1989
Decision
66d
Days
Class 2
Risk

K884647 is an FDA 510(k) clearance for the USCI ADJUSTABLE TIP GUIDE WIRE. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Billerica, US). The FDA issued a Cleared decision on January 12, 1989 after a review of 66 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all C.R. Bard, Inc. devices

Submission Details

510(k) Number K884647 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 1988
Decision Date January 12, 1989
Days to Decision 66 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
59d faster than avg
Panel avg: 125d · This submission: 66d
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 498
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K884647.
ACS 0.015 & 0.018 PRESSURE GUIDE WIRE W/MICRO.
K882507 · Advanced Cardiovascular Systems, Inc. · Mar 1989
ACS 0.010 HI-TORQUE FLOPPY GOLD GUIDE WIRE
K884895 · Advanced Cardiovascular Systems, Inc. · Feb 1989
INTRODUCER SAFETY SYRINGE
K884490 · Arrow Intl., Inc. · Jan 1989
BUCHBINDER MULTIFLEX GUIDEWIRE
K884274 · Medtronic Vascular · Dec 1988
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