Cleared Traditional

K922972 - MODELS 438-05 AND 435-05 IMPLANTABLE PA...

K922972 is an FDA 510(k) clearance for MODELS 438-05 AND 435-05 IMPLANTABLE PA..., manufactured by Intermedics, Inc.. The device is a Class 3 Cardiovascular device with product code DTB cleared through the Traditional 510(k) pathway after a 217-day FDA review.

K922972 · Intermedics, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Jan 1993
Decision
217d
Days
Class 3
Risk

K922972 is an FDA 510(k) clearance for the MODELS 438-05 AND 435-05 IMPLANTABLE PACING LEAD. Classified as Permanent Pacemaker Electrode (product code DTB), Class III - Premarket Approval.

Submitted by Intermedics, Inc. (Angleton, US). The FDA issued a Cleared decision on January 22, 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 Intermedics, Inc. devices

FDA 510(k) Submission Details - K922972

510(k) Number K922972 FDA.gov
FDA Decision Cleared Substantially Equivalent - Product Development Protocol (SESP)
Date Received June 19, 1992
Decision Date January 22, 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.

DTB Device Classification - Class 3, Premarket Approval

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 396
Devices cleared under the same product code (DTB) and FDA review panel - the closest regulatory comparables to K922972.
MAXIMA FILTERED HARDSHELL RESERVOIR
K932254 · Medtronic Vascular · Aug 1993
POSSIS MEDICAL MYOPORE BIPOLAR SUTURELESS MYCARDIA
K925099 · Possis Medical, Inc. · Jun 1993
CARDIFIX ENDOCARDIAL PACING LEAD
K922042 · Intermedics, Inc. · Apr 1993
MEDTRONIC MODELS 5069 AND 5071 MYOCARDIAL PACING
K915736 · Medtronic Vascular · Dec 1992
MODEL P IN-LINE BIPOLAR ENDOCARDIAL TINED LEAD
K915188 · Cook Pacemaker Corp. · Sep 1992
MODELS 6917T, 6917AT & 4951M EPICARDIAL PACE LEADS
K921124 · Medtronic Vascular · May 1992