Cleared Traditional

K980582 - MULTI-LINK CABLE AND LEAD WIRE SYSTEMS

K980582 is an FDA 510(k) clearance for MULTI-LINK CABLE AND LEAD WIRE SYSTEMS, manufactured by Marquette Medical Systems, Inc.. The device is a Class 2 Cardiovascular device with product code DSA cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K980582 · Marquette Medical Systems, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1998
Decision
27d
Days
Class 2
Risk

K980582 is an FDA 510(k) clearance for the MULTI-LINK CABLE AND LEAD WIRE SYSTEMS. Classified as Cable, Transducer And Electrode, Patient, (including Connector) (product code DSA), Class II - Special Controls.

Submitted by Marquette Medical Systems, Inc. (Jupiter, US). The FDA issued a Cleared decision on March 16, 1998 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2900 - 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 Marquette Medical Systems, Inc. devices

FDA 510(k) Submission Details - K980582

510(k) Number K980582 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 1998
Decision Date March 16, 1998
Days to Decision 27 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
98d faster than avg
Panel avg: 125d · This submission: 27d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DSA Device Classification - Class 2, Special Controls

Product Code DSA Cable, Transducer And Electrode, Patient, (including Connector)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2900
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 - DSA Cable, Transducer And Electrode, Patient, (including Connector)

All 59
Devices cleared under the same product code (DSA) and FDA review panel - the closest regulatory comparables to K980582.
DISPOSABLE SURGICAL EXTENSION CABLE, MODEL 4255 AND MODEL 4260
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BIOSENSE WEBSTER PATIENT CABLE AND LEADWIRES
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AFFINITY MEDICAL PATIENT CABLE SYSTEM
K980806 · Affinity Medical Technologies, LLC · Mar 1998
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K971968 · Remington Medical, Inc. · Jul 1997
MODEL 5471 & 5471L STERILE DISPOSABLE PATIENT CABLE ASSEMBLIES
K960446 · Medtronic Vascular · May 1996
CONMED ECG PATIENT SAFETY CABLES AND LEADWIRES-REMOVAL AND PERMANENTLY-ATTACHED LEADWIRES
K945034 · Conmedcorp · Oct 1994