Cleared Traditional

K852918 - SLIM ART J. BIP PACING LEAD USING POLY ...

K852918 is an FDA 510(k) clearance for SLIM ART J. BIP PACING LEAD USING POLY ..., manufactured by Telectronics, Inc.. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K852918 · Telectronics, Inc. · Cardiovascular device
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Jul 1985
Decision
35d
Days
Class 2
Risk

K852918 is an FDA 510(k) clearance for the SLIM ART J. BIP PACING LEAD USING POLY #030-2821. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Telectronics, Inc. (Suffield, US). The FDA issued a Cleared decision on July 29, 1985 after a review of 35 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1340 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Telectronics, Inc. devices

FDA 510(k) Submission Details - K852918

510(k) Number K852918 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 1985
Decision Date July 29, 1985
Days to Decision 35 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
90d faster than avg
Panel avg: 125d · This submission: 35d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DYB Device Classification - Class 2, Special Controls

Product Code DYB Introducer, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1340
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DYB Introducer, Catheter

All 409
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K852918.
PTCA GUIDING CATHETER
K851947 · Cordis Corp. · Aug 1985
SLIM VENT BIPO PACING LEAD USING A90 INSUL,#30-284
K852916 · Telectronics, Inc. · Jul 1985
SLIM ART/J-SVC IND PACING LEAD USING POLY #30-283
K852917 · Telectronics, Inc. · Jul 1985
PERCUTANEOUS ANGIOGRAPHIC NEEDLES
K845037 · Mallinckrodt Critical Care · Jun 1985
DESERET INTRODUCER SET
K844840 · Parke-Davis Co. · May 1985
TELEFLEX MEDICAL INTRODUCER CATHETER
K851141 · Teleflexmedical, Inc. · May 1985