Cleared Traditional

K961668 - MICROFERRET CATHETER

K961668 is an FDA 510(k) clearance for MICROFERRET CATHETER, manufactured by Cook, Inc.. The device is a Class 2 Cardiovascular device with product code KRA cleared through the Traditional 510(k) pathway after a 188-day FDA review.

K961668 · Cook, Inc. · Cardiovascular device
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Nov 1996
Decision
188d
Days
Class 2
Risk

K961668 is an FDA 510(k) clearance for the MICROFERRET CATHETER. Classified as Catheter, Continuous Flush (product code KRA), Class II - Special Controls.

Submitted by Cook, Inc. (Bloomington, US). The FDA issued a Cleared decision on November 4, 1996 after a review of 188 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 Cook, Inc. devices

FDA 510(k) Submission Details - K961668

510(k) Number K961668 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 1996
Decision Date November 04, 1996
Days to Decision 188 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
63d slower than avg
Panel avg: 125d · This submission: 188d
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 150
Devices cleared under the same product code (KRA) and FDA review panel - the closest regulatory comparables to K961668.
CES INFUSION CATHETER
K965181 · Cordis Neurovascular, Inc. · Mar 1997
SEGUE INFUSION CATHETER
K964154 · Interventional Innovations Corp. · Jan 1997
INTRAVASCULAR INFUSION DEVICE
K963988 · Boston Scientific Corp · Dec 1996
FLOWER INFUSION CATHETER MODEL F-25/50, F-60/70
K955525 · Interventional Innovations Corp. · Aug 1996
SEQUE INFUSION CATHETER (S-25,30,35,40,45,50,60)
K955534 · International Innovations, Inc. · Aug 1996
SCIMED DISPATCH GOLD CORONARY CATHETER
K961294 · Scimed Life Systems, Inc. · Jul 1996