Cleared Traditional

K932172 - MEDTRONIC MODELS 4057M

K932172 is the FDA 510(k) clearance for MEDTRONIC MODELS 4057M by Medtronic Vascular. It is a Class 3 Cardiovascular device (product code DTB) cleared through the Traditional 510(k) pathway after a 217-day FDA review.

K932172 · Medtronic Vascular · Cardiovascular device

Download Printable Device Report (PDF)

Optimized for regulatory review, auditing and printing

Dec 1993

Decision

217d

Days

Class 3

Risk

K932172 is an FDA 510(k) clearance for the MEDTRONIC MODELS 4057M,4058M,4557M, PACING LEADS. Classified as Permanent Pacemaker Electrode (product code DTB), Class III - Premarket Approval.

Submitted by Medtronic Vascular (Minneapolis, US). The FDA issued a Cleared decision on December 8, 1993 after a review of 217 days - an extended review 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 Medtronic Vascular devices

Submission Details

510(k) Number	K932172 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Product Development Protocol (SESP)
Date Received	May 05, 1993
Decision Date	December 08, 1993
Days to Decision	217 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF
Third-party Review	No - reviewed directly by FDA
Combination Product	No
PCCP Authorized	No

Regulatory Context

Review time vs. panel average

92d slower than avg

Panel avg: 125d · This submission: 217d

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 364

Devices cleared under the same product code (DTB) and FDA review panel - the closest regulatory comparables to K932172.

MEDTRONIC MODEL 4558M

K940703 · Medtronic Vascular · Nov 1994

MEDTRONIS(R) PACING LEADS AND LEAD ADAPTORS, MODIF

K933055 · Medtronic Vascular · May 1994

MEDTRONIC MODEL 5028 TARGET TIP, BIPOLAR, IMPLANTABLE, TINED, VENTRICULAR, TRANSVENOUS LEAD

K933731 · Medtronic Vascular · Mar 1994

MEDTRONIC MODEL 4081,4581,4582 TARGET TIP PACING L

K931411 · Medtronic Vascular · Sep 1993

MAXIMA FILTERED HARDSHELL RESERVOIR

K932254 · Medtronic Vascular · Aug 1993

POSSIS MEDICAL MYOPORE BIPOLAR SUTURELESS MYCARDIA

K925099 · Possis Medical, Inc. · Jun 1993

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K932172

Medtronic Vascular

Minneapolis, MN · US

TRACY A MALM

Regulatory profile

475 submissions 453 cleared

95% clearance rate · Active in Cardiovascular

Data Intelligence Layer

This record restructures FDA 510(k) public data into device-level regulatory intelligence - enabling comparison across product codes, clearance pathways, review times and manufacturer patterns.

Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

Verify on FDA.gov

510k Database

510(k) clearances indexed 175,730

Regulatory data since 1976

FDA monthly sync Active