Cleared Special

BENEPHIT BIFURCATED INFUSION CATHETER AND 5FR. INTRODUCER SHEATH (K050205) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K050205 · Flowmedica, Inc. · Cardiovascular device
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Mar 2005
Decision
35d
Days
Class 2
Risk

K050205 is an FDA 510(k) clearance for the BENEPHIT BIFURCATED INFUSION CATHETER AND 5FR. INTRODUCER SHEATH. Classified as Catheter, Continuous Flush (product code KRA), Class II - Special Controls.

Submitted by Flowmedica, Inc. (Fremont, US). The FDA issued a Cleared decision on March 4, 2005 after a review of 35 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 Flowmedica, Inc. devices

Submission Details

510(k) Number K050205 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 2005
Decision Date March 04, 2005
Days to Decision 35 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
90d faster than avg
Panel avg: 125d · This submission: 35d
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 173
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