Cleared Traditional

K941058 - PROCATH PACING THRESHOLD CABLE

K941058 is an FDA 510(k) clearance for PROCATH PACING THRESHOLD CABLE, manufactured by Professional Catheter Corp.. The device is a Class 2 Cardiovascular device with product code DSA cleared through the Traditional 510(k) pathway after a 125-day FDA review.

K941058 · Professional Catheter Corp. · Cardiovascular device
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Jul 1994
Decision
125d
Days
Class 2
Risk

K941058 is an FDA 510(k) clearance for the PROCATH PACING THRESHOLD CABLE. Classified as Cable, Transducer And Electrode, Patient, (including Connector) (product code DSA), Class II - Special Controls.

Submitted by Professional Catheter Corp. (Berlin, US). The FDA issued a Cleared decision on July 11, 1994 after a review of 125 days - within the typical 510(k) review window.

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 Professional Catheter Corp. devices

FDA 510(k) Submission Details - K941058

510(k) Number K941058 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 1994
Decision Date July 11, 1994
Days to Decision 125 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
At panel average
Panel avg: 125d · This submission: 125d
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 82
Devices cleared under the same product code (DSA) and FDA review panel - the closest regulatory comparables to K941058.
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CONMED ECG PATIENT SAFETY CABLES AND LEADWIRES-REMOVAL AND PERMANENTLY-ATTACHED LEADWIRES
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CONMED ECG PATIENT CABLES AND LEADWIRES
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DISPOSABLE SURGICAL EXTENSION CABLE MODEL S-101
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MODEL 4280 SURGICAL EXTENSION CABLE
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