Cleared Traditional

K834342 - CCS MODEL AV-102 IMPLANTABLE A-V DATA

K834342 is the FDA 510(k) clearance for CCS MODEL AV-102 IMPLANTABLE A-V DATA by Cardiac Control Systems, Inc.. It is a Class 3 Cardiovascular device (product code DTB) cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K834342 · Cardiac Control Systems, Inc. · Cardiovascular device
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Feb 1984
Decision
54d
Days
Class 3
Risk

K834342 is an FDA 510(k) clearance for the CCS MODEL AV-102 IMPLANTABLE A-V DATA. Classified as Permanent Pacemaker Electrode (product code DTB), Class III - Premarket Approval.

Submitted by Cardiac Control Systems, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 4, 1984 after a review of 54 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: High-complexity regulatory submission. High regulatory complexity profile. 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 K834342 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 1983
Decision Date February 04, 1984
Days to Decision 54 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 125d · This submission: 54d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DTB Permanent Pacemaker Electrode
Device Class Class 3 - Premarket Approval
CFR Regulation 21 CFR 870.3680
What this classification means

Class III devices typically require Premarket Approval (PMA) with clinical evidence. Clearance through 510(k) for Class III devices is granted only when substantial equivalence to a valid predicate can be established.

Regulatory Peers - DTB Permanent Pacemaker Electrode

All 387
Devices cleared under the same product code (DTB) and FDA review panel - the closest regulatory comparables to K834342.
LIFELINE TLE 476-04
K843393 · Intermedics, Inc. · Sep 1984
LIFELINE TLE 484-02
K843394 · Intermedics, Inc. · Sep 1984
PACING ELECTRODE
K834431 · Pacesetter Systems · Mar 1984
ELECTRODE LEAD CONSTRUCTION
K834533 · Telectronics, Inc. · Jan 1984
ENDOCARDIAL SCREW-IN LEAD 859 & 861
K833824 · Pacesetter Systems · Dec 1983
IMPLANTABLE ENDOCARDIAL PACING LEADS
K831997 · Oscor, Inc. · Oct 1983