Cleared Traditional

VASCOSCREW 6/60 AND VASCOSCREW 8/60 (K914121) - FDA 510(k) Clearance

Class III device cleared through the 510(k) pathway via substantial equivalence to a legally marketed predicate.

K914121 · Vascor Medical Corp. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Aug 1993
Decision
711d
Days
Class 3
Risk

K914121 is an FDA 510(k) clearance for the VASCOSCREW 6/60 AND VASCOSCREW 8/60. Classified as Permanent Pacemaker Electrode (product code DTB), Class III - Premarket Approval.

Submitted by Vascor Medical Corp. (Tarpon Springs, US). The FDA issued a Cleared decision on August 24, 1993 after a review of 711 days - an unusually long review period, suggesting complex equivalence evaluation.

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. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Vascor Medical Corp. devices

Submission Details

510(k) Number K914121 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 1991
Decision Date August 24, 1993
Days to Decision 711 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
586d slower than avg
Panel avg: 125d · This submission: 711d
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 187
Devices cleared under the same product code (DTB) and FDA review panel - the closest regulatory comparables to K914121.
MEDTRONIC MODEL 5028 TARGET TIP, BIPOLAR, IMPLANTABLE, TINED, VENTRICULAR, TRANSVENOUS LEAD
K933731 · Medtronic Vascular · Mar 1994
MEDTRONIC MODELS 4057M,4058M,4557M, PACING LEADS
K932172 · Medtronic Vascular · Dec 1993
MEDTRONIC MODEL 4081,4581,4582 TARGET TIP PACING L
K931411 · Medtronic Vascular · Sep 1993
MAXIMA FILTERED HARDSHELL RESERVOIR
K932254 · Medtronic Vascular · Aug 1993
CARDIFIX ENDOCARDIAL PACING LEAD
K922042 · Intermedics, Inc. · Apr 1993
MODELS 438-05 AND 435-05 IMPLANTABLE PACING LEAD
K922972 · Intermedics, Inc. · Jan 1993