Cleared Traditional

K953417 - MINIFLEX MODEL 340

K953417 is the FDA 510(k) clearance for MINIFLEX MODEL 340 by Cook Pacemaker Corp.. It is a Class 3 Cardiovascular device (product code DXY) cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K953417 · Cook Pacemaker Corp. · Cardiovascular device
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Sep 1995
Decision
113d
Days
Class 3
Risk

K953417 is an FDA 510(k) clearance for the MINIFLEX MODEL 340, 341, AND 342 PULSE GENERATORS. Classified as Implantable Pacemaker Pulse-generator (product code DXY), Class III - Premarket Approval.

Submitted by Cook Pacemaker Corp. (Leechburg, US). The FDA issued a Cleared decision on September 29, 1995 after a review of 113 days - within the typical 510(k) review window.

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 Cook Pacemaker Corp. devices

Submission Details

510(k) Number K953417 FDA.gov
FDA Decision Cleared Substantially Equivalent - Third Party Review (ST)
Date Received June 08, 1995
Decision Date September 29, 1995
Days to Decision 113 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
12d faster than avg
Panel avg: 125d · This submission: 113d
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 339
Devices cleared under the same product code (DXY) and FDA review panel - the closest regulatory comparables to K953417.
MINIX 834M & MINIX ST 8331M PULSE GENERATORS (MODIFICATION)
K953866 · Medtronic Vascular · Dec 1995
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K954092 · Medtronic Vascular · Dec 1995
NANOS, PIKOS 01/E01, 01-A, E01-B, LP 01/LP E01
K952328 · Biotronik, Inc. · Sep 1995
OPUS PACEMAKERS (MODELS 4001, 4003, 4004, 4023, 4024)
K952364 · Ela Medical, Inc. · Sep 1995
PELLETHANE 75D
K940039 · Medtronic Vascular · Jul 1995
TECOTHANE 75D POLYURETHANE RESIN FOR PULSE GENERATOR CONNECTOR MODULES
K950751 · Medtronic Vascular · May 1995