Cleared Traditional

INTRODUCER, PERCUTANEOUS SELDINGER (K812964) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K812964 · Triad Medical Division · Cardiovascular device
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Nov 1981
Decision
25d
Days
Class 2
Risk

K812964 is an FDA 510(k) clearance for the INTRODUCER, PERCUTANEOUS SELDINGER. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Triad Medical Division (Walker, US). The FDA issued a Cleared decision on November 16, 1981 after a review of 25 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 Triad Medical Division devices

Submission Details

510(k) Number K812964 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 1981
Decision Date November 16, 1981
Days to Decision 25 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
100d faster than avg
Panel avg: 125d · This submission: 25d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 272
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K812964.
MEDTRONIC 6210 PERMANENT LEAD INTRODUC
K842780 · Medtronic Vascular · Aug 1984
ARGYLE INTRAMEDICUT CATHETER KIT
K821324 · Sherwood Medical Co. · Jul 1982
PERCOR PERCUTANEOUS INTRODUCER
K820834 · Datascope Corp. · Apr 1982
IMPLANTAID LEAD INTRODUCER #319-10 & 12
K812502 · Intermedics, Inc. · Oct 1981
USCI MULLINS TRANSSEPTAL CATHETER INTRO.
K791963 · C.R. Bard, Inc. · Nov 1979
CATHETER INTRODUCERS, ARTERISE
K781954 · C.R. Bard, Inc. · Nov 1978