Cleared Traditional

K844593 - CARDIOVASCULAR CUSTOM SURGICAL KIT

K844593 is an FDA 510(k) clearance for CARDIOVASCULAR CUSTOM SURGICAL KIT, manufactured by Xanmed Corp.. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Traditional 510(k) pathway after a 207-day FDA review.

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

FDA 510(k) Submission Details - K844593

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.

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 616
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K844593.
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
SLIM ART J. BIP PACING LEAD USING POLY #030-2821
K852918 · Telectronics, Inc. · Jul 1985
PERCUTANEOUS ANGIOGRAPHIC NEEDLES
K845037 · Mallinckrodt Critical Care · Jun 1985
DESERET INTRODUCER SET
K844840 · Parke-Davis Co. · May 1985
TELEFLEX MEDICAL INTRODUCER CATHETER
K851141 · Teleflexmedical, Inc. · May 1985