Cleared Traditional

K821324 - ARGYLE INTRAMEDICUT CATHETER KIT

K821324 is an FDA 510(k) clearance for ARGYLE INTRAMEDICUT CATHETER KIT, manufactured by Sherwood Medical Co.. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K821324 · Sherwood Medical Co. · Cardiovascular device
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Jul 1982
Decision
71d
Days
Class 2
Risk

K821324 is an FDA 510(k) clearance for the ARGYLE INTRAMEDICUT CATHETER KIT. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Sherwood Medical Co. (Mchenry, US). The FDA issued a Cleared decision on July 14, 1982 after a review of 71 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 Sherwood Medical Co. devices

FDA 510(k) Submission Details - K821324

510(k) Number K821324 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 1982
Decision Date July 14, 1982
Days to Decision 71 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
54d faster than avg
Panel avg: 125d · This submission: 71d
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 598
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K821324.
MODEL SP5800 #8 FRENCH INTRO. KIT
K823262 · Gould, Inc. · Jan 1983
PERCUTANEOUS CATHETER INTRODUCER SET
K822593 · Vertex Medical Corp. · Sep 1982
CATH-SEAL
K822247 · Universal Medical Instrument Corp. · Aug 1982
INTRODUCER SET
K821188 · Advanced Cardiovascular Systems, Inc. · Jul 1982
PERCOR PERCUTANEOUS INTRODUCER
K820834 · Datascope Corp. · Apr 1982
NEONATAL INTRODUCER KIT
K820710 · Norton Performance Plastics Corp. · Apr 1982