Cleared Traditional

K770416 - LEAD

K770416 is an FDA 510(k) clearance for LEAD, manufactured by Arco Medical Products Co.. The device is a Class 3 Cardiovascular device with product code DTB cleared through the Traditional 510(k) pathway after a 6-day FDA review.

K770416 · Arco Medical Products Co. · Cardiovascular device
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Mar 1977
Decision
6d
Days
Class 3
Risk

K770416 is an FDA 510(k) clearance for the LEAD, HEART, BUTTERFLY CLAMP. Classified as Permanent Pacemaker Electrode (product code DTB), Class III - Premarket Approval.

Submitted by Arco Medical Products Co. (Mchenry, US). The FDA issued a Cleared decision on March 10, 1977 after a review of 6 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 Arco Medical Products Co. devices

FDA 510(k) Submission Details - K770416

510(k) Number K770416 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 1977
Decision Date March 10, 1977
Days to Decision 6 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
119d faster than avg
Panel avg: 125d · This submission: 6d
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 412
Devices cleared under the same product code (DTB) and FDA review panel - the closest regulatory comparables to K770416.
ENDOCARD. PACING LEAD-LONG LENGTH PL203
K771567 · Daig Corp. · Sep 1977
UNIPOLAR LEAD CONFIGURATION CONDUCTOR
K770468 · Daig Corp. · Apr 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