Cleared Traditional

K954020 - MICRO THERAPEUTICS SIDEHOLE INFUSION WIRE

K954020 is the FDA 510(k) clearance for MICRO THERAPEUTICS SIDEHOLE INFUSION WIRE by Micro Therapeutics, Inc.. It is a Class 2 Cardiovascular device (product code KRA) cleared through the Traditional 510(k) pathway after a 158-day FDA review.

K954020 · Micro Therapeutics, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1996
Decision
158d
Days
Class 2
Risk

K954020 is an FDA 510(k) clearance for the MICRO THERAPEUTICS SIDEHOLE INFUSION WIRE. Classified as Catheter, Continuous Flush (product code KRA), Class II - Special Controls.

Submitted by Micro Therapeutics, Inc. (Aliso Viejo, US). The FDA issued a Cleared decision on January 2, 1996 after a review of 158 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 Micro Therapeutics, Inc. devices

Submission Details

510(k) Number K954020 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 1995
Decision Date January 02, 1996
Days to Decision 158 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
33d slower than avg
Panel avg: 125d · This submission: 158d
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 89
Devices cleared under the same product code (KRA) and FDA review panel - the closest regulatory comparables to K954020.
MICROFERRET CATHETER
K961668 · Cook, Inc. · Nov 1996
SCIMED DISPATCH GOLD CORONARY CATHETER
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
SCIMED(R) CORONARY GUIDE WIRE EXCHANGE/INFUSION CATHETER
K945593 · Scimed Life Systems, Inc. · Jan 1995