Cleared Traditional

K800356 - PERMANENT LEAD INTRADUCER

K800356 is an FDA 510(k) clearance for PERMANENT LEAD INTRADUCER, manufactured by Daig Corp.. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Traditional 510(k) pathway after a 103-day FDA review.

K800356 · Daig Corp. · Cardiovascular device
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May 1980
Decision
103d
Days
Class 2
Risk

K800356 is an FDA 510(k) clearance for the PERMANENT LEAD INTRADUCER. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Daig Corp. (Mchenry, US). The FDA issued a Cleared decision on May 28, 1980 after a review of 103 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. 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 Daig Corp. devices

FDA 510(k) Submission Details - K800356

510(k) Number K800356 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 15, 1980
Decision Date May 28, 1980
Days to Decision 103 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
22d faster than avg
Panel avg: 125d · This submission: 103d
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 618
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K800356.
DESILET
K813143 · Exco, Inc. · Nov 1981
IMPLANTAID LEAD INTRODUCER #319-10 & 12
K812502 · Intermedics, Inc. · Oct 1981
INTK-08 8 FRENCH INTRODUCER KIT W/SIDE
K812325 · Sorensen Research · Sep 1981
THERMODILUTION CATHETER INTRO. KIT
K800619 · Norton Performance Plastics Corp. · Apr 1980
VENOUS M/A INTERNAL JUGULAR KIT
K800620 · Norton Performance Plastics Corp. · Apr 1980
PERCUTANEOUS CATHETER INTRODUCER ADAPTER
K800621 · Norton Performance Plastics Corp. · Apr 1980