Cleared Traditional

K781954 - CATHETER INTRODUCERS

K781954 is the FDA 510(k) clearance for CATHETER INTRODUCERS by C.R. Bard, Inc.. It is a Class 2 Cardiovascular device (product code DYB) cleared through the Traditional 510(k) pathway after a 8-day FDA review.

K781954 · C.R. Bard, Inc. · Cardiovascular device
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Nov 1978
Decision
8d
Days
Class 2
Risk

K781954 is an FDA 510(k) clearance for the CATHETER INTRODUCERS, ARTERISE. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 29, 1978 after a review of 8 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 C.R. Bard, Inc. devices

Submission Details

510(k) Number K781954 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 1978
Decision Date November 29, 1978
Days to Decision 8 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
117d faster than avg
Panel avg: 125d · This submission: 8d
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 390
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K781954.
PERCUTANEOUS CATHETER INTRODUCER ADAPTER
K800621 · Norton Performance Plastics Corp. · Apr 1980
USCI MULLINS TRANSSEPTAL CATHETER INTRO.
K791963 · C.R. Bard, Inc. · Nov 1979
PERMANENT LEAD INTRADUCER
K791129 · Daig Corp. · Jul 1979
PERCUTANEOUS SHEATH INTRODUCER KIT
K780532 · Arrow Intl., Inc. · Apr 1978
INTRODUCER, CAT. #INT-06FR.
K771041 · Sorensen Research · Jul 1977
INTRODUCER, CAT. #INT-05FR.
K771042 · Sorensen Research · Jul 1977