Cleared Traditional

K972518 - TRANSIT/RAPIDTRANSIT/SPEEDSTER/PROWLER ...

K972518 is the FDA 510(k) clearance for TRANSIT/RAPIDTRANSIT/SPEEDSTER/PROWLER ... by Cordis Neurovascular, Inc.. It is a Class 2 Cardiovascular device (product code KRA) cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K972518 · Cordis Neurovascular, Inc. · Cardiovascular device
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Nov 1997
Decision
120d
Days
Class 2
Risk

K972518 is an FDA 510(k) clearance for the TRANSIT/RAPIDTRANSIT/SPEEDSTER/PROWLER 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 November 4, 1997 after a review of 120 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

Submission Details

510(k) Number K972518 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 1997
Decision Date November 04, 1997
Days to Decision 120 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
5d faster than avg
Panel avg: 125d · This submission: 120d
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 124
Devices cleared under the same product code (KRA) and FDA review panel - the closest regulatory comparables to K972518.
FLOW RIDER FLOW DIRECTED MICRO CATHETER
K980104 · Micro Therapeutics, Inc. · Apr 1998
CES MASSTRANSIT INFUSION CATHETER
K974222 · Cordis Neurovascular, Inc. · Feb 1998
RENEGADE FIBER BRAIDED MICROCATHETER
K973645 · Boston Scientific Corp · Nov 1997
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