Cleared Traditional

K771041 - INTRODUCER

K771041 is the FDA 510(k) clearance for INTRODUCER by Sorensen Research. It is a Class 2 Cardiovascular device (product code DYB) cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K771041 · Sorensen Research · Cardiovascular device
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Jul 1977
Decision
34d
Days
Class 2
Risk

K771041 is an FDA 510(k) clearance for the INTRODUCER, CAT. #INT-06FR.. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Sorensen Research (Mchenry, US). The FDA issued a Cleared decision on July 13, 1977 after a review of 34 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 Sorensen Research devices

Submission Details

510(k) Number K771041 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 1977
Decision Date July 13, 1977
Days to Decision 34 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
91d faster than avg
Panel avg: 125d · This submission: 34d
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 324
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K771041.
USCI MULLINS TRANSSEPTAL CATHETER INTRO.
K791963 · C.R. Bard, Inc. · Nov 1979
CATHETER INTRODUCERS, ARTERISE
K781954 · C.R. Bard, Inc. · Nov 1978
PERCUTANEOUS SHEATH INTRODUCER KIT
K780532 · Arrow Intl., Inc. · Apr 1978
INTRODUCER, CAT. #INT-05FR.
K771042 · Sorensen Research · Jul 1977
INTRODUCER, CAT. #INT-07FR.
K771040 · Sorensen Research · Jun 1977