Cleared Traditional

K933603 - LEADWIRE

K933603 is an FDA 510(k) clearance for LEADWIRE, manufactured by Sentry Medical Products, Inc.. The device is a Class 2 Cardiovascular device with product code DSA cleared through the Traditional 510(k) pathway after a 175-day FDA review.

K933603 · Sentry Medical Products, Inc. · Cardiovascular device
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Jan 1994
Decision
175d
Days
Class 2
Risk

K933603 is an FDA 510(k) clearance for the LEADWIRE. Classified as Cable, Transducer And Electrode, Patient, (including Connector) (product code DSA), Class II - Special Controls.

Submitted by Sentry Medical Products, Inc. (Irvine, US). The FDA issued a Cleared decision on January 18, 1994 after a review of 175 days - an extended review 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: 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 Sentry Medical Products, Inc. devices

FDA 510(k) Submission Details - K933603

510(k) Number K933603 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 1993
Decision Date January 18, 1994
Days to Decision 175 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d slower than avg
Panel avg: 125d · This submission: 175d
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 79
Devices cleared under the same product code (DSA) and FDA review panel - the closest regulatory comparables to K933603.
TRONOMATE PATIENT CABLE & LEADWIRE SYSTEM
K952659 · Tronomed, Inc. · Jan 1996
CONMED ECG PATIENT SAFETY CABLES AND LEADWIRES-REMOVAL AND PERMANENTLY-ATTACHED LEADWIRES
K945034 · Conmedcorp · Oct 1994
CONMED ECG PATIENT CABLES AND LEADWIRES
K933649 · Conmedcorp · Feb 1994
DISPOSABLE SURGICAL EXTENSION CABLE MODEL S-101
K922009 · Remington Medical, Inc. · Feb 1993
MODEL 4280 SURGICAL EXTENSION CABLE
K922899 · Pace Medical · Dec 1992
RTM 36-05, 60-05, RTD 36-05, 60-05 RADIO. LEADWIRE
K901780 · Medtronic Vascular · Oct 1990