Cleared Traditional

K161967 - FluidiTube 2.7F Infusion Micro Catheter

K161967 is an FDA 510(k) clearance for FluidiTube 2.7F Infusion Micro Catheter, manufactured by Callisyn Biomedical, Inc.. The device is a Class 2 Cardiovascular device with product code KRA cleared through the Traditional 510(k) pathway after a 193-day FDA review.

K161967 · Callisyn Biomedical, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
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Jan 2017
Decision
193d
Days
Class 2
Risk

K161967 is an FDA 510(k) clearance for the FluidiTube 2.7F Infusion Micro Catheter, 110 cm and 130 cm. Classified as Catheter, Continuous Flush (product code KRA), Class II - Special Controls.

Submitted by Callisyn Biomedical, Inc. (North Andover, US). The FDA issued a Cleared decision on January 27, 2017 after a review of 193 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 Callisyn Biomedical, Inc. devices

FDA 510(k) Submission Details - K161967

510(k) Number K161967 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 2016
Decision Date January 27, 2017
Days to Decision 193 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
68d slower than avg
Panel avg: 125d · This submission: 193d
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 134
Devices cleared under the same product code (KRA) and FDA review panel - the closest regulatory comparables to K161967.
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