Cleared Traditional

K843798 - MEADOX SURGIMED A/S CATHETER SHEATH SYS

K843798 is the FDA 510(k) clearance for MEADOX SURGIMED A/S CATHETER SHEATH SYS by Meadox Surgimed, Inc.. It is a Class 2 Cardiovascular device (product code DYB) cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K843798 · Meadox Surgimed, Inc. · Cardiovascular device
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Dec 1984
Decision
91d
Days
Class 2
Risk

K843798 is an FDA 510(k) clearance for the MEADOX SURGIMED A/S CATHETER SHEATH SYS. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Meadox Surgimed, Inc. (Oakland, US). The FDA issued a Cleared decision on December 27, 1984 after a review of 91 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Meadox Surgimed, Inc. devices

Submission Details

510(k) Number K843798 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 1984
Decision Date December 27, 1984
Days to Decision 91 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 125d · This submission: 91d
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 397
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K843798.
DESERET INTRODUCER SET
K844840 · Parke-Davis Co. · May 1985
TELEFLEX MEDICAL INTRODUCER CATHETER
K851141 · Teleflexmedical, Inc. · May 1985
PEEL-AWAY INTRODUCER SET
K844693 · Quinton, Inc. · Mar 1985
MEDTRONIC 6210 PERMANENT LEAD INTRODUC
K842780 · Medtronic Vascular · Aug 1984
EMERGENCY INFUSION DEVICE
K840455 · Arrow Intl., Inc. · May 1984
ANGIOGRAPHY NEEDLE W/WO CONNECTION
K840923 · Dlp, Inc. · Apr 1984