Cleared Traditional

K853747 - NAVIGATOR

K853747 is an FDA 510(k) clearance for NAVIGATOR, manufactured by Mainsfield Scientific, Inc.. The device is a Class 3 Cardiovascular device with product code DTB cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K853747 · Mainsfield Scientific, Inc. · Cardiovascular device
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Jan 1986
Decision
121d
Days
Class 3
Risk

K853747 is an FDA 510(k) clearance for the NAVIGATOR. Classified as Permanent Pacemaker Electrode (product code DTB), Class III - Premarket Approval.

Submitted by Mainsfield Scientific, Inc. (Mansfield, US). The FDA issued a Cleared decision on January 8, 1986 after a review of 121 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 Mainsfield Scientific, Inc. devices

FDA 510(k) Submission Details - K853747

510(k) Number K853747 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 1985
Decision Date January 08, 1986
Days to Decision 121 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d faster than avg
Panel avg: 125d · This submission: 121d
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 424
Devices cleared under the same product code (DTB) and FDA review panel - the closest regulatory comparables to K853747.
STYLET INTRODUCER FUNNEL
K854142 · Telectronics, Inc. · Jan 1986
POLYSAFE CCS TRIFIX ENDOCARDIAL PACING LEAD SV-107
K853446 · Cardiac Control Systems, Inc. · Jan 1986
MOD TARGET/TIPS # 4011,4012,4511,4512,6912,4016
K854582 · Medtronic Vascular · Jan 1986
POLYFLEX 483-09 ENDOCARDIAL IMPLANTABLE PACINGLEAD
K854069 · Intermedics, Inc. · Dec 1985
IMPLANT ELECT LEAD MOD 30-404 USING POLYU 90 A
K852710 · Telectronics, Inc. · Dec 1985
CCS MODEL BV-114 IMPLANTABLE ENDOCARDIAL BIPOLARPA
K853294 · Cardiac Control Systems, Inc. · Dec 1985