Cleared Traditional

K822834 - ACCESS PERCUTANEOUS INTRODUCER SET

K822834 is an FDA 510(k) clearance for ACCESS PERCUTANEOUS INTRODUCER SET, manufactured by Access Devices, Inc.. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K822834 · Access Devices, Inc. · Cardiovascular device
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Nov 1982
Decision
41d
Days
Class 2
Risk

K822834 is an FDA 510(k) clearance for the ACCESS PERCUTANEOUS INTRODUCER SET. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Access Devices, Inc. (Walker, US). The FDA issued a Cleared decision on November 1, 1982 after a review of 41 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 Access Devices, Inc. devices

FDA 510(k) Submission Details - K822834

510(k) Number K822834 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 1982
Decision Date November 01, 1982
Days to Decision 41 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 125d · This submission: 41d
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 646
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K822834.
FRENCH PERCUTANEOUS SHEATH INTRODUCER
K830813 · Norton Performance Plastics Corp. · Apr 1983
CORONARY GUIDING CATHETER
K830829 · Advanced Cardiovascular Systems, Inc. · Apr 1983
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
ARGYLE INTRAMEDICUT CATHETER KIT
K821324 · Sherwood Medical Co. · Jul 1982