Cleared Traditional

K770468 - UNIPOLAR LEAD CONFIGURATION CONDUCTOR

K770468 is the FDA 510(k) clearance for UNIPOLAR LEAD CONFIGURATION CONDUCTOR by Daig Corp.. It is a Class 3 Cardiovascular device (product code DTB) cleared through the Traditional 510(k) pathway after a 26-day FDA review.

K770468 · Daig Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1977
Decision
26d
Days
Class 3
Risk

K770468 is an FDA 510(k) clearance for the UNIPOLAR LEAD CONFIGURATION CONDUCTOR. Classified as Permanent Pacemaker Electrode (product code DTB), Class III - Premarket Approval.

Submitted by Daig Corp. (Mchenry, US). The FDA issued a Cleared decision on April 5, 1977 after a review of 26 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 Daig Corp. devices

Submission Details

510(k) Number K770468 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 1977
Decision Date April 05, 1977
Days to Decision 26 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
99d faster than avg
Panel avg: 125d · This submission: 26d
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 386
Devices cleared under the same product code (DTB) and FDA review panel - the closest regulatory comparables to K770468.
ENDOCARD. PACIN/ LEAD-LONG LENGTH PL200
K771565 · Daig Corp. · Sep 1977
ENDOCAR. PACING LEAD-STD. LENGTH PL202
K771566 · Daig Corp. · Sep 1977
ENDOCARD. PACING LEAD-LONG LENGTH PL203
K771567 · Daig Corp. · Sep 1977
TEMP. PERVENOUS LEAD W/REMOTE ANODE
K770214 · Cordis Corp. · Mar 1977
PERM. IMPLANT. ENDOCARDIAL PAC. LEAD
K770195 · Daig Corp. · Feb 1977
CARDIAC ELECTRODE
K760443 · Meadox Medicals, Div. Boston Scientific Corp. · Aug 1976