Cleared Traditional

SEQUE INFUSION CATHETER (S-25,30,35,40,45,50,60) (K955534) - FDA 510(k) Clearance

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

K955534 · International Innovations, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1996
Decision
241d
Days
Class 2
Risk

K955534 is an FDA 510(k) clearance for the SEQUE INFUSION CATHETER (S-25,30,35,40,45,50,60). Classified as Catheter, Continuous Flush (product code KRA), Class II - Special Controls.

Submitted by International Innovations, Inc. (St. Paul, US). The FDA issued a Cleared decision on August 1, 1996 after a review of 241 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 International Innovations, Inc. devices

Submission Details

510(k) Number K955534 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 1995
Decision Date August 01, 1996
Days to Decision 241 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
116d slower than avg
Panel avg: 125d · This submission: 241d
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 K955534.
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
SAFESET RESERVOIR
K932188 · Abbott Laboratories · Oct 1993
SWAN-GANZ INTELLICATH CCO THERMODILUTION CATHETER
K924661 · Baxter Healthcare Corp · Apr 1993