Cleared Traditional

K844752 - TRANSVENOUS BALLOON TIPPED(FLOW DIRECTE...

K844752 is the FDA 510(k) clearance for TRANSVENOUS BALLOON TIPPED(FLOW DIRECTE... by Mansfield Scientific, Inc.. It is a Class 3 Cardiovascular device (product code DTB) cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K844752 · Mansfield Scientific, Inc. · Cardiovascular device
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Jan 1985
Decision
27d
Days
Class 3
Risk

K844752 is an FDA 510(k) clearance for the TRANSVENOUS BALLOON TIPPED(FLOW DIRECTED) TEMP. PA. Classified as Permanent Pacemaker Electrode (product code DTB), Class III - Premarket Approval.

Submitted by Mansfield Scientific, Inc. (Mansfield, US). The FDA issued a Cleared decision on January 2, 1985 after a review of 27 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 Mansfield Scientific, Inc. devices

Submission Details

510(k) Number K844752 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 1984
Decision Date January 02, 1985
Days to Decision 27 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
98d faster than avg
Panel avg: 125d · This submission: 27d
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 365
Devices cleared under the same product code (DTB) and FDA review panel - the closest regulatory comparables to K844752.
MODELS 4012/4512 TRANSVENOUS TINED-
K842032 · Medtronic Vascular · Jan 1985
MEDTRONIC 6304, 6305,6306,6506 & 6506W. TEMP.PACIN
K844959 · Medtronic Vascular · Jan 1985
MEDTRONIC 6957J
K843707 · Medtronic Vascular · Jan 1985
CORDIS ENCOR ATRIAL LEAD
K811259 · Cordis Corp. · Dec 1984
MEDTRONIC 6957
K843706 · Medtronic Vascular · Dec 1984
LIFELINE TLE 476-04
K843393 · Intermedics, Inc. · Sep 1984