Cleared Traditional

K954457 - MEDI-TECH EDDY INTRAVASCULAR INFUSION C...

K954457 is the FDA 510(k) clearance for MEDI-TECH EDDY INTRAVASCULAR INFUSION C... by Medi-Tech, Inc.. It is a Class 2 Cardiovascular device (product code KRA) cleared through the Traditional 510(k) pathway after a 233-day FDA review.

K954457 · Medi-Tech, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
May 1996
Decision
233d
Days
Class 2
Risk

K954457 is an FDA 510(k) clearance for the MEDI-TECH EDDY INTRAVASCULAR INFUSION CATHETER. Classified as Catheter, Continuous Flush (product code KRA), Class II - Special Controls.

Submitted by Medi-Tech, Inc. (Natick,, US). The FDA issued a Cleared decision on May 15, 1996 after a review of 233 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 Medi-Tech, Inc. devices

Submission Details

510(k) Number K954457 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 1995
Decision Date May 15, 1996
Days to Decision 233 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
108d slower than avg
Panel avg: 125d · This submission: 233d
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 80
Devices cleared under the same product code (KRA) and FDA review panel - the closest regulatory comparables to K954457.
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K961294 · Scimed Life Systems, Inc. · Jul 1996
SCIMED DISPATCH CORONARY INFUSION CATHETER
K953133 · Scimed Life Systems, Inc. · Feb 1996
SSCIMED CORONARY GUIDE WIRE/INFUSION CATHETER
K952872 · Scimed Life Systems, Inc. · Jul 1995
EVOLUTION(TM) MICROCATHETER
K945666 · Boston Scientific Corp · Jun 1995