Cleared Traditional

K843290 - NUMED BALLOON PACING CATHETER

K843290 is the FDA 510(k) clearance for NUMED BALLOON PACING CATHETER by NuMED, Inc.. It is a Class 2 Cardiovascular device (product code LDF) cleared through the Traditional 510(k) pathway after a 146-day FDA review.

K843290 · NuMED, Inc. · Cardiovascular device
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Jan 1985
Decision
146d
Days
Class 2
Risk

K843290 is an FDA 510(k) clearance for the NUMED BALLOON PACING CATHETER. Classified as Electrode, Pacemaker, Temporary (product code LDF), Class II - Special Controls.

Submitted by NuMED, Inc. (Hopkinton, US). The FDA issued a Cleared decision on January 14, 1985 after a review of 146 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3680 - 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 NuMED, Inc. devices

Submission Details

510(k) Number K843290 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 1984
Decision Date January 14, 1985
Days to Decision 146 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
21d slower than avg
Panel avg: 125d · This submission: 146d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LDF Electrode, Pacemaker, Temporary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3680
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 - LDF Electrode, Pacemaker, Temporary

All 75
Devices cleared under the same product code (LDF) and FDA review panel - the closest regulatory comparables to K843290.
NUMED TEMP. STYLET PACING PAROBE 1318694
K851845 · NuMED, Inc. · Aug 1985
NUMED BALLOON PACING CATHETER
K851246 · NuMED, Inc. · Apr 1985
ELECATH OPEN TIP BIPOLAR PACING CATHETER
K850324 · Electro-Catheter Corp. · Mar 1985
ELECATH VENTRICULAR PACING WEDGE PRESSURE CATH
K844003 · Electro-Catheter Corp. · Dec 1984
CRITIKON HEPARIN-COATED CARDIOVASCULAR
K843141 · Critikon Company, LLC · Sep 1984
LUMELEC ELECTRODE CATHETER
K834416 · Cordis Corp. · Apr 1984