Cleared Traditional

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

K955534 is an FDA 510(k) clearance for SEQUE INFUSION CATHETER (S-25, manufactured by International Innovations, Inc.. The device is a Class 2 Cardiovascular device with product code KRA cleared through the Traditional 510(k) pathway after a 241-day FDA review.

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

FDA 510(k) Submission Details - K955534

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
Combination Product No
PCCP Authorized No
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.

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 K955534.
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
SCIMED DISPATCH GOLD CORONARY CATHETER
K961294 · Scimed Life Systems, Inc. · Jul 1996
MX703 AND MX730 CONTINUOUS FLUSH DEVICES
K961527 · Medex, Inc. · Jun 1996
MEDI-TECH EDDY INTRAVASCULAR INFUSION CATHETER
K954457 · Medi-Tech, Inc. · May 1996