Cleared Traditional

K965189 - SPINNAKER

K965189 is the FDA 510(k) clearance for SPINNAKER by Target Therapeutics. It is a Class 2 Cardiovascular device (product code KRA) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K965189 · Target Therapeutics · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1997
Decision
90d
Days
Class 2
Risk

K965189 is an FDA 510(k) clearance for the SPINNAKER. Classified as Catheter, Continuous Flush (product code KRA), Class II - Special Controls.

Submitted by Target Therapeutics (Freemont, US). The FDA issued a Cleared decision on March 24, 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 Target Therapeutics devices

Submission Details

510(k) Number K965189 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 24, 1996
Decision Date March 24, 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.

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 127
Devices cleared under the same product code (KRA) and FDA review panel - the closest regulatory comparables to K965189.
FG INFUSION CATHETER
K971306 · Cordis Neurovascular, Inc. · Jul 1997
2.9F CRAGG-MCNAMARA VALVED INFUSION CATHETER
K964868 · Micro Therapeutics, Inc. · May 1997
CONTINUOUS FLUSH DEVICE
K962129 · Merit Medical Systems, Inc. · Apr 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