Cleared Traditional

K964154 - SEGUE INFUSION CATHETER

K964154 is an FDA 510(k) clearance for SEGUE INFUSION CATHETER, manufactured by Interventional Innovations Corp.. The device is a Class 2 Cardiovascular device with product code KRA cleared through the Traditional 510(k) pathway after a 90-day FDA review.

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

FDA 510(k) Submission Details - K964154

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
Combination Product No
PCCP Authorized No
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.

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 147
Devices cleared under the same product code (KRA) and FDA review panel - the closest regulatory comparables to K964154.
CONTINUOUS FLUSH DEVICE
K962129 · Merit Medical Systems, Inc. · Apr 1997
SPINNAKER
K965189 · Target Therapeutics · Mar 1997
CES INFUSION CATHETER
K965181 · Cordis Neurovascular, Inc. · Mar 1997
INTRAVASCULAR INFUSION DEVICE
K963988 · Boston Scientific Corp · Dec 1996
MICROFERRET CATHETER
K961668 · Cook, Inc. · Nov 1996
FLOWER INFUSION CATHETER MODEL F-25/50, F-60/70
K955525 · Interventional Innovations Corp. · Aug 1996