Cleared Traditional

SEGUE INFUSION CATHETER (K964154) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K964154 · Interventional Innovations Corp. · Cardiovascular device
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Jan 1997
Decision
90d
Days
Class 2
Risk

K964154 is an FDA 510(k) clearance for the SEGUE INFUSION CATHETER. Classified as Catheter, Continuous Flush (product code KRA), Class II - Special Controls.

Submitted by Interventional Innovations Corp. (St. Paul, US). The FDA issued a Cleared decision on January 14, 1997 after a review of 90 days - within the typical 510(k) review window.

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 Interventional Innovations Corp. devices

Submission Details

510(k) Number K964154 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 1996
Decision Date January 14, 1997
Days to Decision 90 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
35d faster than avg
Panel avg: 125d · This submission: 90d
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 65
Devices cleared under the same product code (KRA) and FDA review panel - the closest regulatory comparables to K964154.
RENEGADE HI-FLO MICROCATHETER
K000177 · Boston Scientific Corp · Apr 2000
RENEGADE FIBER BRAIDED MICROCATHETER
K973645 · Boston Scientific Corp · Nov 1997
CONTINUOUS FLUSH DEVICE
K962129 · Merit Medical Systems, Inc. · Apr 1997
INTRAVASCULAR INFUSION DEVICE
K963988 · Boston Scientific Corp · Dec 1996
MICROFERRET CATHETER
K961668 · Cook, Inc. · Nov 1996
EVOLUTION(TM) MICROCATHETER
K945666 · Boston Scientific Corp · Jun 1995