Cleared Traditional

K820883 - SEPTISLEEVE

K820883 is the FDA 510(k) clearance for SEPTISLEEVE by Argon Medical Corp.. It is a Class 2 Cardiovascular device (product code DYG) cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K820883 · Argon Medical Corp. · Cardiovascular device
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Apr 1982
Decision
30d
Days
Class 2
Risk

K820883 is an FDA 510(k) clearance for the SEPTISLEEVE. Classified as Catheter, Flow Directed (product code DYG), Class II - Special Controls.

Submitted by Argon Medical Corp. (Mchenry, US). The FDA issued a Cleared decision on April 29, 1982 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1240 - 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 K820883 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 1982
Decision Date April 29, 1982
Days to Decision 30 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 125d · This submission: 30d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DYG Catheter, Flow Directed
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1240
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 - DYG Catheter, Flow Directed

All 54
Devices cleared under the same product code (DYG) and FDA review panel - the closest regulatory comparables to K820883.
SWAN-GANZ FLOW-DIRECTED THERMODIL. CATH
K822350 · American Edwards Laboratories · Aug 1982
LEONARD PERIPHERAL VENOUS PRESSURE CATH
K821996 · Norton Performance Plastics Corp. · Jul 1982
MEDTRONIC S3 TM SYSTEM
K821004 · Medtronic Vascular · May 1982
IL 7F FLOW DIRECTOR THERMAL DILU. CATH
K820702 · Instrumentation Laboratory CO · Apr 1982
SWAN-GANZ VIP-CATHETER
K820222 · American Edwards Laboratories · Feb 1982
NORTON FLOW DIRECTED THERMODILUTION CATH
K820229 · Norton Performance Plastics Corp. · Feb 1982