Cleared Traditional

MODEL 1148T TRANSVENOUS, SCREW-IN LEAD (K925347) - FDA 510(k) Clearance

Class III device cleared through the 510(k) pathway via substantial equivalence to a legally marketed predicate.

K925347 · Siemens-Pacesetter, Inc. · Cardiovascular device
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Jun 1993
Decision
231d
Days
Class 3
Risk

K925347 is an FDA 510(k) clearance for the MODEL 1148T TRANSVENOUS, SCREW-IN LEAD. Classified as Permanent Pacemaker Electrode (product code DTB), Class III - Premarket Approval.

Submitted by Siemens-Pacesetter, Inc. (Sylmar, US). The FDA issued a Cleared decision on June 10, 1993 after a review of 231 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 Siemens-Pacesetter, Inc. devices

Submission Details

510(k) Number K925347 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 1992
Decision Date June 10, 1993
Days to Decision 231 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
106d slower than avg
Panel avg: 125d · This submission: 231d
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 187
Devices cleared under the same product code (DTB) and FDA review panel - the closest regulatory comparables to K925347.
MEDTRONIC MODELS 4057M,4058M,4557M, PACING LEADS
K932172 · Medtronic Vascular · Dec 1993
MEDTRONIC MODEL 4081,4581,4582 TARGET TIP PACING L
K931411 · Medtronic Vascular · Sep 1993
MAXIMA FILTERED HARDSHELL RESERVOIR
K932254 · Medtronic Vascular · Aug 1993
CARDIFIX ENDOCARDIAL PACING LEAD
K922042 · Intermedics, Inc. · Apr 1993
MODELS 438-05 AND 435-05 IMPLANTABLE PACING LEAD
K922972 · Intermedics, Inc. · Jan 1993
MEDTRONIC MODELS 5069 AND 5071 MYOCARDIAL PACING
K915736 · Medtronic Vascular · Dec 1992