Cleared Traditional

K945909 - NAVARRE N-FUSER(TM) PERIPHERAL INFUSION...

K945909 is an FDA 510(k) clearance for NAVARRE N-FUSER(TM) PERIPHERAL INFUSION..., manufactured by Navarre Biomedical , Ltd.. The device is a Class 2 Cardiovascular device with product code KRA cleared through the Traditional 510(k) pathway after a 182-day FDA review.

K945909 · Navarre Biomedical , Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1995
Decision
182d
Days
Class 2
Risk

K945909 is an FDA 510(k) clearance for the NAVARRE N-FUSER(TM) PERIPHERAL INFUSION CATHETER. Classified as Catheter, Continuous Flush (product code KRA), Class II - Special Controls.

Submitted by Navarre Biomedical , Ltd. (Plymouth, US). The FDA issued a Cleared decision on June 2, 1995 after a review of 182 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 Navarre Biomedical , Ltd. devices

FDA 510(k) Submission Details - K945909

510(k) Number K945909 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 1994
Decision Date June 02, 1995
Days to Decision 182 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
57d slower than avg
Panel avg: 125d · This submission: 182d
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 129
Devices cleared under the same product code (KRA) and FDA review panel - the closest regulatory comparables to K945909.
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K931335 · Scimed Life Systems, Inc. · Jul 1994
SCIMED(R) DISPATCH(TM) CORONARY INFUSION CATHETER
K932616 · Scimed Life Systems, Inc. · Dec 1993