Cleared Traditional

K161967 - FluidiTube 2.7F Infusion Micro Catheter, 110 cm and 130 cm (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K161967 · Callisyn Biomedical, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

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 172
Devices cleared under the same product code (KRA) and FDA review panel - the closest regulatory comparables to K161967.
InVera Infusion Device
K250794 · Invera Medical · Mar 2026
Micro Catheter
K243534 · Suzhou Zenith Vascular SciTech Limited · Jul 2025
XO Cath Microcatheter (E20-090-S, E20-110-S, E20-130-S, E20-150-S, E20-175-S, E20-220-S, E20-090-B, E20-110-B, E20-130-B, E20-150-B, E20-175-B, E20-220-B, E26-090-S, E26-110-S, E26-130-S, E26-150-S, E26-175-S, E26-220-S, E26-090-B, E26-110-B, E26-130-B, E26-150-B, E26-175-B, E26-220-B,)
K231821 · Transit Scientific, LLC · Nov 2023
Peregrine System Infusion Catheter 4-7 mm, Peregrine System Infusion Catheter 3-4 mm
K231279 · Ablative Solutions, Inc. · Jul 2023
ScleroSafe™ 150 mm, ScleroSafe™ 350 mm
K231148 · Vvt Medical , Ltd. · Jun 2023
TriSalus TriNav® LV Infusion System
K230957 · Trisalus Life Sciences · May 2023