Cleared Traditional

K033569 - FLOWMEDICA BIFURCATED INFUSION SYSTEM, INFUSION CATHETER AND INTRODUCER SHEATH

K033569 is an FDA 510(k) clearance for FLOWMEDICA BIFURCATED INFUSION SYSTEM, manufactured by Flowmedica, Inc.. The device is a Class 2 Cardiovascular device with product code KRA cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K033569 · Flowmedica, Inc. · Cardiovascular device
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Jan 2004
Decision
62d
Days
Class 2
Risk

K033569 is an FDA 510(k) clearance for the FLOWMEDICA BIFURCATED INFUSION SYSTEM, INFUSION CATHETER AND 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 January 13, 2004 after a review of 62 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 Flowmedica, Inc. devices

FDA 510(k) Submission Details - K033569

510(k) Number K033569 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 2003
Decision Date January 13, 2004
Days to Decision 62 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
63d faster than avg
Panel avg: 125d · This submission: 62d
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 137
Devices cleared under the same product code (KRA) and FDA review panel - the closest regulatory comparables to K033569.
ECHELON 10,45 TIP SHAPE MICRO CATHETER ECHELON 10,90 TIP SHAPE MICRO CATHETER, ECHELON 14,45 TIP SHAPE MICRO CATHETER,90
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PROGREAT
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ECHELON MICRO CATHETER, MODEL 105-5092-150
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K024122 · Micro Therapeutics, Inc. · Mar 2003