Cleared Special

K021591 - PROWLER SELECT (10

K021591 is the FDA 510(k) clearance for PROWLER SELECT (10 by Cordis Neurovascular, Inc.. It is a Class 2 Cardiovascular device (product code KRA) cleared through the Special 510(k) pathway after a 7-day FDA review.

K021591 · Cordis Neurovascular, Inc. · Cardiovascular device
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May 2002
Decision
7d
Days
Class 2
Risk

K021591 is an FDA 510(k) clearance for the PROWLER SELECT (10, 14, AND PLUS) INFUSION CATHETERS WITH AND WITHOUT PRE-SHA.... Classified as Catheter, Continuous Flush (product code KRA), Class II - Special Controls.

Submitted by Cordis Neurovascular, Inc. (Miami Lake, US). The FDA issued a Cleared decision on May 22, 2002 after a review of 7 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1210 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Cordis Neurovascular, Inc. devices

Submission Details

510(k) Number K021591 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 2002
Decision Date May 22, 2002
Days to Decision 7 days
Submission Type Special
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
118d faster than avg
Panel avg: 125d · This submission: 7d
Pathway characteristics
Modification to existing cleared device.

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 K021591.
ECHELON MICRO CATHETER, MODEL 105-5092-150
K030688 · Micro Therapeutics, Inc. · Mar 2003
NAUTICA MICRO CATHETER, MODEL 105-5094-153
K024122 · Micro Therapeutics, Inc. · Mar 2003
ULTRAFLOW HPC FLOW DIRECTED MICRO CATHETER, MODELS 105-5065 AND 105-5066
K024118 · Micro Therapeutics, Inc. · Feb 2003
PROWLER SELECT 10 AND 14 INFUSION CATHETERS WITH AND WITHOUT PRE-SHAPED TIPS
K020680 · Cordis Neurovascular, Inc. · Mar 2002
FLOWRIDER FLOW DIRECTED MICRO CATHETER, MODEL 105-5065
K010004 · Micro Therapeutics, Inc. · Feb 2001
PROWLER INFUSION CATHETERS WITH PRE-SHAPED TIPS
K003925 · Cordis Neurovascular, Inc. · Jan 2001