Cleared Traditional

K971775 - INTERIM AV SHAPED TEMPORARY PACING CATHETER MODEL INT-AV610

K971775 is an FDA 510(k) clearance for INTERIM AV SHAPED TEMPORARY PACING CATH..., manufactured by Cardiac Control Systems, Inc.. The device is a Class 2 Cardiovascular device with product code LDF cleared through the Traditional 510(k) pathway after a 230-day FDA review.

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

FDA 510(k) Submission Details - K971775

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
Combination Product No
PCCP Authorized No
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.

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 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
SAFPACE SYSTEM
K955829 · B.Braun Medical, Inc. · Nov 1997
HARMAC TEMPORARY PACING CATHETER WITH BALLOON
K962833 · Harmac Medical Products, Inc. · Oct 1997
HARMAC BIPOLAR TEMPORARY PACING CATHETER WITH STYLET
K963073 · Harmac Medical Products, Inc. · Aug 1997