Cleared Traditional

K852797 - HEPARIN COAT TRAN BALLO TIP TEMP PAC ELECTRODE

K852797 is an FDA 510(k) clearance for HEPARIN COAT TRAN BALLO TIP TEMP PAC EL..., manufactured by Mansfield Scientific, Inc.. The device is a Class 2 Cardiovascular device with product code LDF cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K852797 · Mansfield Scientific, Inc. · Cardiovascular device
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Sep 1985
Decision
80d
Days
Class 2
Risk

K852797 is an FDA 510(k) clearance for the HEPARIN COAT TRAN BALLO TIP TEMP PAC ELECTRODE. Classified as Electrode, Pacemaker, Temporary (product code LDF), Class II - Special Controls.

Submitted by Mansfield Scientific, Inc. (Mansfield, US). The FDA issued a Cleared decision on September 16, 1985 after a review of 80 days - a notably fast clearance cycle.

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: 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 Mansfield Scientific, Inc. devices

FDA 510(k) Submission Details - K852797

510(k) Number K852797 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 1985
Decision Date September 16, 1985
Days to Decision 80 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 125d · This submission: 80d
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 93
Devices cleared under the same product code (LDF) and FDA review panel - the closest regulatory comparables to K852797.
MEDTRONIC MODEL 6405
K853818 · Medtronic Vascular · Oct 1985
CORDIS HIGH-TORQUE TEMP. PERVENOUS LEAD W/DEPTH MA
K851913 · Cordis Corp. · Sep 1985
115-GK BARD CARE TRANSLU VENTRICULAR PACING LEAD
K852513 · C.R. Bard, Inc. · Sep 1985
NUMED TEMP. STYLET PACING PAROBE 1318694
K851845 · NuMED, Inc. · Aug 1985
NUMED BALLOON PACING CATHETER
K851246 · NuMED, Inc. · Apr 1985
OSCOR MEDICAL MODEL TME 64S BIPOLAR TEMP/HEART WIR
K850622 · Oscor Medical Corp. · Apr 1985