Cleared Traditional

K024122 - NAUTICA MICRO CATHETER, MODEL 105-5094-153

K024122 is an FDA 510(k) clearance for NAUTICA MICRO CATHETER, manufactured by Micro Therapeutics, Inc.. The device is a Class 2 Cardiovascular device with product code KRA cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K024122 · Micro Therapeutics, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2003
Decision
81d
Days
Class 2
Risk

K024122 is an FDA 510(k) clearance for the NAUTICA MICRO CATHETER, MODEL 105-5094-153. Classified as Catheter, Continuous Flush (product code KRA), Class II - Special Controls.

Submitted by Micro Therapeutics, Inc. (Irvine, US). The FDA issued a Cleared decision on March 7, 2003 after a review of 81 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Micro Therapeutics, Inc. devices

FDA 510(k) Submission Details - K024122

510(k) Number K024122 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 2002
Decision Date March 07, 2003
Days to Decision 81 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
44d faster than avg
Panel avg: 125d · This submission: 81d
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 139
Devices cleared under the same product code (KRA) and FDA review panel - the closest regulatory comparables to K024122.
MARATHON FLOW DIRECTED MICRO CATHETER, MODEL 105-5055
K034036 · Micro Therapeutics, Inc. · Feb 2004
ECHELON MICRO CATHETER, MODEL 105-5091
K031992 · Micro Therapeutics, Inc. · Aug 2003
ECHELON MICRO CATHETER, MODEL 105-5092-150
K030688 · 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, 14, AND PLUS) INFUSION CATHETERS WITH AND WITHOUT PRE-SHAPED TIPS
K021591 · Cordis Neurovascular, Inc. · May 2002
PROWLER SELECT 10 AND 14 INFUSION CATHETERS WITH AND WITHOUT PRE-SHAPED TIPS
K020680 · Cordis Neurovascular, Inc. · Mar 2002