Cleared Traditional

K910924 - ENDOCARDIAL LEADS-MOD. TO THE POLYVINYLPYRROLIDONE

K910924 is an FDA 510(k) clearance for ENDOCARDIAL LEADS-MOD. TO THE POLYVINYL..., manufactured by Pacesetter Systems. The device is a Class 3 Cardiovascular device with product code DTB cleared through the Traditional 510(k) pathway after a 176-day FDA review.

K910924 · Pacesetter Systems · Cardiovascular device
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Aug 1991
Decision
176d
Days
Class 3
Risk

K910924 is an FDA 510(k) clearance for the ENDOCARDIAL LEADS-MOD. TO THE POLYVINYLPYRROLIDONE. Classified as Permanent Pacemaker Electrode (product code DTB), Class III - Premarket Approval.

Submitted by Pacesetter Systems (Sylmar, US). The FDA issued a Cleared decision on August 28, 1991 after a review of 176 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 Pacesetter Systems devices

FDA 510(k) Submission Details - K910924

510(k) Number K910924 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 1991
Decision Date August 28, 1991
Days to Decision 176 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
51d slower than avg
Panel avg: 125d · This submission: 176d
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 423
Devices cleared under the same product code (DTB) and FDA review panel - the closest regulatory comparables to K910924.
IMPLANT PACING LEAD, RETRACTABLE, MODIFICATION
K913393 · Oscor Medical Corp. · Sep 1991
MODELS 432-03 & 433-03 IMPLANT ENDOCARD PAC LEAD
K912235 · Intermedics, Inc. · Sep 1991
PERMANENT IMPLANTABLE JP ENDOCARDIAL LEADS W/TIP
K910609 · Biotronik, GmbH & Co. · Aug 1991
100 CM PERMANENT PACING LEAD MODELS
K911273 · Telectronics Pacing Systems, Inc. · Aug 1991
BIPOLAR SUTURELESS MYOCARDIAL PACING LEADS
K910528 · Possis Medical, Inc. · Aug 1991
PERMANENT IMPLANTABLE FH ENDOCARDIAL LEADS W/TIP
K910608 · Biotronik, GmbH & Co. · Jul 1991