Cleared Traditional

K924388 - ANGEMED MODEL 4000 QC BIPOLAR TEMP PACING LEAD

K924388 is an FDA 510(k) clearance for ANGEMED MODEL 4000 QC BIPOLAR TEMP PACI..., manufactured by Angemed, Inc.. The device is a Class 2 Cardiovascular device with product code LDF cleared through the Traditional 510(k) pathway after a 416-day FDA review.

K924388 · Angemed, Inc. · Cardiovascular device
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Oct 1993
Decision
416d
Days
Class 2
Risk

K924388 is an FDA 510(k) clearance for the ANGEMED MODEL 4000 QC BIPOLAR TEMP PACING LEAD. Classified as Electrode, Pacemaker, Temporary (product code LDF), Class II - Special Controls.

Submitted by Angemed, Inc. (Minneapolis, US). The FDA issued a Cleared decision on October 21, 1993 after a review of 416 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Angemed, Inc. devices

FDA 510(k) Submission Details - K924388

510(k) Number K924388 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 1992
Decision Date October 21, 1993
Days to Decision 416 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
291d slower than avg
Panel avg: 125d · This submission: 416d
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 K924388.
MULTIPACE
K934785 · Electro-Catheter Corp. · Jul 1995
SILICORE SEMI-FLOATER
K934787 · Electro-Catheter Corp. · Feb 1995
BIPOLAR BALLOON PACING CATHETER BY J-LLOYD
K930069 · J-Lloyd Medical, Inc. · Jan 1994
UNIPOLAR ATRIAL TEMPORARY PACING LEAD, MODEL 6492
K922182 · Medtronic Vascular · Nov 1992
UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD MOD. 6491
K922268 · Medtronic Vascular · Nov 1992
MEDTRONIC MODELS 5455L AND 5455SL SURGICAL CABLES
K923407 · Medtronic Vascular · Oct 1992