Cleared Traditional

K900645 - LASERDISH POLYURETHANE VENTRICULAR LEAD W/TRAILING

K900645 is an FDA 510(k) clearance for LASERDISH POLYURETHANE VENTRICULAR LEAD..., 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 180-day FDA review.

K900645 · Telectronics Pacing Systems, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1990
Decision
180d
Days
Class 3
Risk

K900645 is an FDA 510(k) clearance for the LASERDISH POLYURETHANE VENTRICULAR LEAD W/TRAILING. 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 August 8, 1990 after a review of 180 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 Telectronics Pacing Systems, Inc. devices

FDA 510(k) Submission Details - K900645

510(k) Number K900645 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 1990
Decision Date August 08, 1990
Days to Decision 180 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
55d slower than avg
Panel avg: 125d · This submission: 180d
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 K900645.
LABEL CHANGE UNIPOLAR ENDOCARDIAL LEAD, DJP 60-UP
K903929 · Biotronik, GmbH & Co. · Oct 1990
MODELS 5069/5071 MYOCARDIAL PACING LEADS
K902002 · Medtronic Vascular · Sep 1990
BIOTRONIK'S PS-ENDOCARDIAL LEADS
K896824 · Biotronik, GmbH & Co. · 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
VS-1 LEAD EXT. 033-302, 4.75MM 033-260, 033-458
K901402 · Telectronics Pacing Systems, Inc. · Jun 1990