Cleared Traditional

K852880 - PEEL-AWAY SHEATH(A COMPONENT OF ARGON I...

K852880 is the FDA 510(k) clearance for PEEL-AWAY SHEATH(A COMPONENT OF ARGON I... by Argon Medical Corp.. It is a Class 2 Cardiovascular device (product code DYB) cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K852880 · Argon Medical Corp. · Cardiovascular device
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Aug 1985
Decision
51d
Days
Class 2
Risk

K852880 is an FDA 510(k) clearance for the PEEL-AWAY SHEATH(A COMPONENT OF ARGON INTROD SET). Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Argon Medical Corp. (Athens, US). The FDA issued a Cleared decision on August 29, 1985 after a review of 51 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 Argon Medical Corp. devices

Submission Details

510(k) Number K852880 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 1985
Decision Date August 29, 1985
Days to Decision 51 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 125d · This submission: 51d
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 392
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K852880.
CORDIS CATHETER SHEATH INTRODUCERS,STERI-SLEEVES
K855126 · Cordis Corp. · Feb 1986
MEDTRONIC PERMANENT LEAD INTRODUCER
K854559 · Medtronic Vascular · Dec 1985
COBE CATHETER W/GUIDEWIRE ASSEMBLY KIT
K853100 · Cobe Laboratories, Inc. · Sep 1985
PTCA GUIDING CATHETER
K851947 · Cordis Corp. · Aug 1985
SLIM VENT BIPO PACING LEAD USING A90 INSUL,#30-284
K852916 · Telectronics, Inc. · Jul 1985
SLIM ART/J-SVC IND PACING LEAD USING POLY #30-283
K852917 · Telectronics, Inc. · Jul 1985