Cleared Traditional

K912235 - MODELS 432-03 & 433-03 IMPLANT ENDOCARD...

K912235 is an FDA 510(k) clearance for MODELS 432-03 & 433-03 IMPLANT ENDOCARD..., 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 127-day FDA review.

K912235 · Intermedics, Inc. · Cardiovascular device
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Sep 1991
Decision
127d
Days
Class 3
Risk

K912235 is an FDA 510(k) clearance for the MODELS 432-03 & 433-03 IMPLANT ENDOCARD PAC LEAD. Classified as Permanent Pacemaker Electrode (product code DTB), Class III - Premarket Approval.

Submitted by Intermedics, Inc. (Freeport, US). The FDA issued a Cleared decision on September 18, 1991 after a review of 127 days - within the typical 510(k) review window.

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 - K912235

510(k) Number K912235 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 1991
Decision Date September 18, 1991
Days to Decision 127 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
2d slower than avg
Panel avg: 125d · This submission: 127d
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 K912235.
MODEL KY PACEMAKER LEAD-VARIOUS, MODIFICATION
K913204 · Oscor Medical Corp. · Sep 1991
OSCOR MEDICAL FIX SCREW PAC LEAD/PEEL CATH, MODIF
K913205 · Oscor Medical Corp. · Sep 1991
IMPLANT PACING LEAD, RETRACTABLE, MODIFICATION
K913393 · Oscor Medical Corp. · Sep 1991
ENDOCARDIAL LEADS-MOD. TO THE POLYVINYLPYRROLIDONE
K910924 · Pacesetter Systems · Aug 1991
BIPOLAR SUTURELESS MYOCARDIAL PACING LEADS
K910528 · Possis Medical, Inc. · Aug 1991
OSCOR MEDICAL CORP. PERMANENT PACING PAD
K905182 · Oscor Medical Corp. · May 1991