Cleared Traditional

K780532 - PERCUTANEOUS SHEATH INTRODUCER KIT

K780532 is an FDA 510(k) clearance for PERCUTANEOUS SHEATH INTRODUCER KIT, manufactured by Arrow Intl., Inc.. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K780532 · Arrow Intl., Inc. · Cardiovascular device
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Apr 1978
Decision
17d
Days
Class 2
Risk

K780532 is an FDA 510(k) clearance for the PERCUTANEOUS SHEATH INTRODUCER KIT. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Arrow Intl., Inc. (Mchenry, US). The FDA issued a Cleared decision on April 21, 1978 after a review of 17 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 Arrow Intl., Inc. devices

FDA 510(k) Submission Details - K780532

510(k) Number K780532 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 1978
Decision Date April 21, 1978
Days to Decision 17 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
108d faster than avg
Panel avg: 125d · This submission: 17d
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 K780532.
USCI MULLINS TRANSSEPTAL CATHETER INTRO.
K791963 · C.R. Bard, Inc. · Nov 1979
PERMANENT LEAD INTRADUCER
K791129 · Daig Corp. · Jul 1979
CATHETER INTRODUCERS, ARTERISE
K781954 · C.R. Bard, Inc. · Nov 1978
INTRODUCER, CAT. #INT-06FR.
K771041 · Sorensen Research · Jul 1977
INTRODUCER, CAT. #INT-05FR.
K771042 · Sorensen Research · Jul 1977
INTRODUCER, CAT. #INT-07FR.
K771040 · Sorensen Research · Jun 1977