Cleared Traditional

CORDIS STEERABLE COATED GUIDEWIRE (K894633) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K894633 · Cordis Corp. · Cardiovascular device

Download Printable Device Report (PDF)

Optimized for regulatory review, auditing and printing

Oct 1989

Decision

85d

Days

Class 2

Risk

K894633 is an FDA 510(k) clearance for the CORDIS STEERABLE COATED GUIDEWIRE. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Cordis Corp. (Miami, US). The FDA issued a Cleared decision on October 17, 1989 after a review of 85 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 Cordis Corp. devices

Submission Details

510(k) Number	K894633 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 24, 1989
Decision Date	October 17, 1989
Days to Decision	85 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

40d faster than avg

Panel avg: 125d · This submission: 85d

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 287

Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K894633.

DATASCOPE SLIDEWIRE(TM)

K901347 · Datascope Corp. · Jun 1990

CRAGG CONVERTIBLE WIRE

K897152 · Boston Scientific Corp · Feb 1990

DATASCOPE STEERING HANDLE

K894940 · Datascope Corp. · Nov 1989

DATASCOPE INTERLOCK GUIDE WIRE EXTENSION

K894318 · Datascope Corp. · Oct 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

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K894633

Cordis Corp.

Miami, FL · US

ROSEMARY SERBENT

Regulatory profile

315 submissions 281 cleared

89% clearance rate · Active in Cardiovascular

Data Intelligence Layer

This record restructures FDA 510(k) public data into device-level regulatory intelligence - enabling comparison across product codes, clearance pathways, review times and manufacturer patterns.

Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

Verify on FDA.gov

510k Database

510(k) clearances indexed 175,450

Regulatory data since 1976

FDA monthly sync Active