Cleared Traditional

K923368 - MAGIC INFUSION CATHETER

K923368 is the FDA 510(k) clearance for MAGIC INFUSION CATHETER by Target Therapeutics. It is a Class 2 Cardiovascular device (product code KRA) cleared through the Traditional 510(k) pathway after a 272-day FDA review.

K923368 · Target Therapeutics · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1993
Decision
272d
Days
Class 2
Risk

K923368 is an FDA 510(k) clearance for the MAGIC INFUSION CATHETER. Classified as Catheter, Continuous Flush (product code KRA), Class II - Special Controls.

Submitted by Target Therapeutics (Freemont, US). The FDA issued a Cleared decision on April 7, 1993 after a review of 272 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1210 - 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 Target Therapeutics devices

Submission Details

510(k) Number K923368 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 1992
Decision Date April 07, 1993
Days to Decision 272 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
147d slower than avg
Panel avg: 125d · This submission: 272d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KRA Catheter, Continuous Flush
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1210
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 - KRA Catheter, Continuous Flush

All 127
Devices cleared under the same product code (KRA) and FDA review panel - the closest regulatory comparables to K923368.
ZEPHYR INFUSION CATHETER
K921247 · Target Therapeutics · Jun 1993
SELECTIVE INFUSION II CATHETER
K914751 · Advanced Cardiovascular Systems, Inc. · May 1993
SWAN-GANZ INTELLICATH CCO THERMODILUTION CATHETER
K924661 · Baxter Healthcare Corp · Apr 1993
E-Z-EM PULSED INFUSION SYSTEM
K905447 · E-Z-Em, Inc. · Apr 1991
VAMP VENOUS/ARTERIAL BLOOD MANAGEMENT PROTECTION
K896819 · Baxter Healthcare Corp · Jan 1990
VAMP VENOUS/ARTERIAL BLOOD MANAGEMENT PROTECTION
K885281 · Baxter Healthcare Corp · Mar 1989