Cleared Traditional

K770214 - TEMP. PERVENOUS LEAD W/REMOTE ANODE

K770214 is an FDA 510(k) clearance for TEMP. PERVENOUS LEAD W/REMOTE ANODE, manufactured by Cordis Corp.. The device is a Class 3 Cardiovascular device with product code DTB cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K770214 · Cordis Corp. · Cardiovascular device
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Mar 1977
Decision
54d
Days
Class 3
Risk

K770214 is an FDA 510(k) clearance for the TEMP. PERVENOUS LEAD W/REMOTE ANODE. Classified as Permanent Pacemaker Electrode (product code DTB), Class III - Premarket Approval.

Submitted by Cordis Corp. (Mchenry, US). The FDA issued a Cleared decision on March 28, 1977 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 Cordis Corp. devices

FDA 510(k) Submission Details - K770214

510(k) Number K770214 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 1977
Decision Date March 28, 1977
Days to Decision 54 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 125d · This submission: 54d
Pathway characteristics
Predicate-based equivalence.

DTB Device Classification - Class 3, Premarket Approval

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 396
Devices cleared under the same product code (DTB) and FDA review panel - the closest regulatory comparables to K770214.
ENDOCAR. PACING LEAD-STD. LENGTH PL202
K771566 · Daig Corp. · Sep 1977
ENDOCARD. PACING LEAD-LONG LENGTH PL203
K771567 · Daig Corp. · Sep 1977
UNIPOLAR LEAD CONFIGURATION CONDUCTOR
K770468 · Daig Corp. · Apr 1977
PERM. IMPLANT. ENDOCARDIAL PAC. LEAD
K770195 · Daig Corp. · Feb 1977
CARDIAC ELECTRODE
K760443 · Meadox Medicals, Div. Boston Scientific Corp. · Aug 1976