Cleared Traditional

K954020 - MICRO THERAPEUTICS SIDEHOLE INFUSION WIRE

K954020 is an FDA 510(k) clearance for MICRO THERAPEUTICS SIDEHOLE INFUSION WIRE, manufactured by Micro Therapeutics, Inc.. The device is a Class 2 Cardiovascular device with 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

FDA 510(k) Submission Details - K954020

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
Combination Product No
PCCP Authorized No
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.

KRA Device Classification - Class 2, Special Controls

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 139
Devices cleared under the same product code (KRA) and FDA review panel - the closest regulatory comparables to K954020.
MX703 AND MX730 CONTINUOUS FLUSH DEVICES
K961527 · Medex, Inc. · Jun 1996
MEDI-TECH EDDY INTRAVASCULAR INFUSION CATHETER
K954457 · Medi-Tech, Inc. · May 1996
SCIMED DISPATCH CORONARY INFUSION CATHETER
K953133 · Scimed Life Systems, Inc. · Feb 1996
TRANSIT INFUSION CATHETER WITH SIDEHOLES
K954949 · Cordis Neurovascular, Inc. · Dec 1995
TRANSIT INFUSION CATHETER
K952874 · Cordis Neurovascular, Inc. · Aug 1995
SSCIMED CORONARY GUIDE WIRE/INFUSION CATHETER
K952872 · Scimed Life Systems, Inc. · Jul 1995