Cleared Traditional

INTERIM AV SHAPED TEMPORARY PACING CATHETER MODEL INT-AV610 (K971775) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K971775 · Cardiac Control Systems, Inc. · Cardiovascular device
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Dec 1997
Decision
230d
Days
Class 2
Risk

K971775 is an FDA 510(k) clearance for the INTERIM AV SHAPED TEMPORARY PACING CATHETER MODEL INT-AV610. Classified as Electrode, Pacemaker, Temporary (product code LDF), Class II - Special Controls.

Submitted by Cardiac Control Systems, Inc. (Palm Coast, US). The FDA issued a Cleared decision on December 29, 1997 after a review of 230 days - an extended review 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: 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 Cardiac Control Systems, Inc. devices

Submission Details

510(k) Number K971775 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 1997
Decision Date December 29, 1997
Days to Decision 230 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
105d slower than avg
Panel avg: 125d · This submission: 230d
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 47
Devices cleared under the same product code (LDF) and FDA review panel - the closest regulatory comparables to K971775.
MODEL 6495 BIPOLAR TEMPORARY MYOCARDIAL PACING LEAD
K012460 · Medtronic Vascular · Aug 2001
MEDTRONIC MODEL 6416 TRANSVENOUS BIPOLAR TEMPORARY PACING LEAD
K973360 · Medtronic Vascular · May 1998
TEMPORARY CARDIAC PACING WIRE
K980503 · Ethicon, Inc. · Apr 1998
INTRODUCER SHEATH AND DILATOR
K971165 · Boston Scientific Corp · Jul 1997
MODEL 6495 BIPOLAR TEMPORARY PACING LEAD
K963898 · Medtronic Vascular · Jul 1997
UNIPOLAR IPG GROUND CABLE, MODEL 5473
K961520 · Medtronic Vascular · Nov 1996