Cleared Traditional

K900622 - MODIFIED MODEL 5401B TEST CABLE

K900622 is the FDA 510(k) clearance for MODIFIED MODEL 5401B TEST CABLE by Medtronic Vascular. It is a Class 3 Cardiovascular device (product code DXY) cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K900622 · Medtronic Vascular · Cardiovascular device
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Apr 1990
Decision
77d
Days
Class 3
Risk

K900622 is an FDA 510(k) clearance for the MODIFIED MODEL 5401B TEST CABLE. Classified as Implantable Pacemaker Pulse-generator (product code DXY), Class III - Premarket Approval.

Submitted by Medtronic Vascular (Minneapolis, US). The FDA issued a Cleared decision on April 26, 1990 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3610 - 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 Medtronic Vascular devices

Submission Details

510(k) Number K900622 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 1990
Decision Date April 26, 1990
Days to Decision 77 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
48d faster than avg
Panel avg: 125d · This submission: 77d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DXY Implantable Pacemaker Pulse-generator
Device Class Class 3 - Premarket Approval
CFR Regulation 21 CFR 870.3610
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 - DXY Implantable Pacemaker Pulse-generator

All 338
Devices cleared under the same product code (DXY) and FDA review panel - the closest regulatory comparables to K900622.
IMPLANTABLE PULSE DEVICES
K903919 · Medtronic Vascular · Oct 1990
MODIFIED MEDTRONIC CLASSIX MODEL 8438 PULSE GENE.
K901535 · Medtronic Vascular · Jul 1990
MINIX, MINIX ST, NEW IC: L74
K902134 · Medtronic Vascular · Jul 1990
OPUS MODEL 4021, VVI, 5MM UNIPOLAR
K900461 · Ela Medical, Inc. · Mar 1990
MEDTRONIC SPECTRAX SXT MODEL 8423M PULSE GENERATOR
K896809 · Medtronic Vascular · Jan 1990
OPUS MODEL 4001
K894065 · Ela Medical, Inc. · Sep 1989