Cleared Traditional

K964868 - 2.9F CRAGG-MCNAMARA VALVED INFUSION CAT...

K964868 is the FDA 510(k) clearance for 2.9F CRAGG-MCNAMARA VALVED INFUSION CAT... by Micro Therapeutics, Inc.. It is a Class 2 Cardiovascular device (product code KRA) cleared through the Traditional 510(k) pathway after a 167-day FDA review.

K964868 · Micro Therapeutics, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
May 1997
Decision
167d
Days
Class 2
Risk

K964868 is an FDA 510(k) clearance for the 2.9F CRAGG-MCNAMARA VALVED INFUSION CATHETER. Classified as Catheter, Continuous Flush (product code KRA), Class II - Special Controls.

Submitted by Micro Therapeutics, Inc. (San Clemente, US). The FDA issued a Cleared decision on May 20, 1997 after a review of 167 days - an extended review 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: 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 Micro Therapeutics, Inc. devices

Submission Details

510(k) Number K964868 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 1996
Decision Date May 20, 1997
Days to Decision 167 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d slower than avg
Panel avg: 125d · This submission: 167d
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 90
Devices cleared under the same product code (KRA) and FDA review panel - the closest regulatory comparables to K964868.
PROGREAT
K033913 · Terumo Medical Corp. · Mar 2004
RENEGADE HI-FLO MICROCATHETER
K000177 · Boston Scientific Corp · Apr 2000
RENEGADE FIBER BRAIDED MICROCATHETER
K973645 · Boston Scientific Corp · Nov 1997
CONTINUOUS FLUSH DEVICE
K962129 · Merit Medical Systems, Inc. · Apr 1997
SPINNAKER
K965189 · Target Therapeutics · Mar 1997
INTRAVASCULAR INFUSION DEVICE
K963988 · Boston Scientific Corp · Dec 1996