Cleared Traditional

K971306 - FG INFUSION CATHETER

K971306 is an FDA 510(k) clearance for FG INFUSION CATHETER, manufactured by Cordis Neurovascular, Inc.. The device is a Class 2 Cardiovascular device with product code KRA cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K971306 · Cordis Neurovascular, Inc. · Cardiovascular device
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Jul 1997
Decision
97d
Days
Class 2
Risk

K971306 is an FDA 510(k) clearance for the FG INFUSION CATHETER. Classified as Catheter, Continuous Flush (product code KRA), Class II - Special Controls.

Submitted by Cordis Neurovascular, Inc. (Miami Lakes, US). The FDA issued a Cleared decision on July 14, 1997 after a review of 97 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 Cordis Neurovascular, Inc. devices

FDA 510(k) Submission Details - K971306

510(k) Number K971306 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 1997
Decision Date July 14, 1997
Days to Decision 97 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
28d faster than avg
Panel avg: 125d · This submission: 97d
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 K971306.
CES MASSTRANSIT INFUSION CATHETER
K974222 · Cordis Neurovascular, Inc. · Feb 1998
RENEGADE FIBER BRAIDED MICROCATHETER
K973645 · Boston Scientific Corp · Nov 1997
TRANSIT/RAPIDTRANSIT/SPEEDSTER/PROWLER INFUSION CATHETER
K972518 · Cordis Neurovascular, Inc. · Nov 1997
2.9F CRAGG-MCNAMARA VALVED INFUSION CATHETER
K964868 · Micro Therapeutics, Inc. · May 1997
CONTINUOUS FLUSH DEVICE
K962129 · Merit Medical Systems, Inc. · Apr 1997
SPINNAKER
K965189 · Target Therapeutics · Mar 1997