Cleared Traditional

K081147 - ISOFLOW INFUSION CATHETER

K081147 is an FDA 510(k) clearance for ISOFLOW INFUSION CATHETER, manufactured by Vascular Designs, Inc.. The device is a Class 2 Cardiovascular device with product code KRA cleared through the Traditional 510(k) pathway after a 402-day FDA review.

K081147 · Vascular Designs, Inc. · Cardiovascular device
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May 2009
Decision
402d
Days
Class 2
Risk

K081147 is an FDA 510(k) clearance for the ISOFLOW INFUSION CATHETER. Classified as Catheter, Continuous Flush (product code KRA), Class II - Special Controls.

Submitted by Vascular Designs, Inc. (Irvine, US). The FDA issued a Cleared decision on May 29, 2009 after a review of 402 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Vascular Designs, Inc. devices

FDA 510(k) Submission Details - K081147

510(k) Number K081147 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 2008
Decision Date May 29, 2009
Days to Decision 402 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
277d slower than avg
Panel avg: 125d · This submission: 402d
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 K081147.
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