Cleared Traditional

K843290 - NUMED BALLOON PACING CATHETER

K843290 is an FDA 510(k) clearance for NUMED BALLOON PACING CATHETER, manufactured by NuMED, Inc.. The device is a Class 2 Cardiovascular device with 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

FDA 510(k) Submission Details - K843290

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.

LDF Device Classification - Class 2, Special Controls

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 92
Devices cleared under the same product code (LDF) and FDA review panel - the closest regulatory comparables to K843290.
NUMED BALLOON PACING CATHETER
K851246 · NuMED, Inc. · Apr 1985
OSCOR MEDICAL MODEL TME 64S BIPOLAR TEMP/HEART WIR
K850622 · Oscor Medical Corp. · 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