Cleared Traditional

K844593 - CARDIOVASCULAR CUSTOM SURGICAL KIT (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K844593 · Xanmed Corp. · Cardiovascular device
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Jun 1985
Decision
207d
Days
Class 2
Risk

K844593 is an FDA 510(k) clearance for the CARDIOVASCULAR CUSTOM SURGICAL KIT. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Xanmed Corp. (Washington, US). The FDA issued a Cleared decision on June 21, 1985 after a review of 207 days - an extended review 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: 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 Xanmed Corp. devices

Submission Details

510(k) Number K844593 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 1984
Decision Date June 21, 1985
Days to Decision 207 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
82d slower than avg
Panel avg: 125d · This submission: 207d
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 700
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