Cleared Traditional

K901402 - VS-1 LEAD EXT. 033-302, 4.75MM 033-260, 033-458

K901402 is an FDA 510(k) clearance for VS-1 LEAD EXT. 033-302, manufactured by Telectronics Pacing Systems, Inc.. The device is a Class 3 Cardiovascular device with product code DTB cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K901402 · Telectronics Pacing Systems, Inc. · Cardiovascular device
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Jun 1990
Decision
78d
Days
Class 3
Risk

K901402 is an FDA 510(k) clearance for the VS-1 LEAD EXT. 033-302, 4.75MM 033-260, 033-458. Classified as Permanent Pacemaker Electrode (product code DTB), Class III - Premarket Approval.

Submitted by Telectronics Pacing Systems, Inc. (Englewood, US). The FDA issued a Cleared decision on June 12, 1990 after a review of 78 days - a notably fast clearance 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 Telectronics Pacing Systems, Inc. devices

FDA 510(k) Submission Details - K901402

510(k) Number K901402 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 1990
Decision Date June 12, 1990
Days to Decision 78 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
47d faster than avg
Panel avg: 125d · This submission: 78d
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 420
Devices cleared under the same product code (DTB) and FDA review panel - the closest regulatory comparables to K901402.
LASERDISH POLYURETHANE VENTRICULAR LEAD W/TRAILING
K900645 · Telectronics Pacing Systems, Inc. · Aug 1990
FOCUS J81F, J83F, J41F, J43F PACING LEADS
K896742 · Ela Medical, Inc. · Jul 1990
ENDOCARDIAL SCREW-IN LEAD MODEL 1028T
K902147 · Pacesetter Systems · Jul 1990
DNP 60-B UNIPOLAR ENDOCARDIAL LEAD
K901709 · Biotronik, GmbH & Co. · May 1990
MODIFIED UNIPOLAR IMPLANT. PACING LEADS W/IS-1
K900984 · Medtronic Vascular · May 1990
FAST-PASS ACE MODELS 1212T/1222T/1216T/1226T
K900550 · Pacesetter Systems · Apr 1990