Cleared Traditional

K850065 - ELECATH TORKFLOAT PACING PROBE

K850065 is the FDA 510(k) clearance for ELECATH TORKFLOAT PACING PROBE by Electro-Catheter Corp.. It is a Class 3 Cardiovascular device (product code DTB) cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K850065 · Electro-Catheter Corp. · Cardiovascular device
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Apr 1985
Decision
92d
Days
Class 3
Risk

K850065 is an FDA 510(k) clearance for the ELECATH TORKFLOAT PACING PROBE. Classified as Permanent Pacemaker Electrode (product code DTB), Class III - Premarket Approval.

Submitted by Electro-Catheter Corp. (Rahway, US). The FDA issued a Cleared decision on April 10, 1985 after a review of 92 days - within the typical 510(k) review window.

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 Electro-Catheter Corp. devices

Submission Details

510(k) Number K850065 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 08, 1985
Decision Date April 10, 1985
Days to Decision 92 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 125d · This submission: 92d
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 274
Devices cleared under the same product code (DTB) and FDA review panel - the closest regulatory comparables to K850065.
SLIM VENT UNIPO PACING LEAD USING POLYU 90A,30-281
K852915 · Telectronics, Inc. · Jul 1985
IMPLANTABLE ELECTRODE ADAPTOR ASSEMBLE
K851461 · Telectronics, Inc. · Jul 1985
IMPLANTABLE ELECTRODE LEAD 030-269 USING POLYURETH
K851296 · Telectronics, Inc. · Apr 1985
IMPLANTABLE ELECTRODE LEAD 030-272 USING POLYURETH
K851294 · Telectronics, Inc. · Apr 1985
IMPLANTABLE ELECTRODE LEAD 030-271 USING POLYURETH
K851295 · Telectronics, Inc. · Apr 1985
IMPLANTABLE ELECTRODE LEAD, 030-270 USING POLYURET
K851297 · Telectronics, Inc. · Apr 1985