Cleared Traditional

K161967 - FluidiTube 2.7F Infusion Micro Catheter, 110 cm and 130 cm

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) Official FDA 510(k) Summary (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.

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
Combination Product No
PCCP Authorized No
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 Consultant

Icon
Gordon MacFarlane

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - KRA Catheter, Continuous Flush

All 168
Devices cleared under the same product code (KRA) and FDA review panel - the closest regulatory comparables to K161967.
CXI TriForce Peripheral Crossing Set
K170931 · Cook Incorporated · Nov 2017
Maestro Microcatheter
K172081 · Merit Medical Systems, Inc. · Aug 2017
Direxion and Direxion HI-FLO Torqueable Microcatheters
K163701 · Boston Scientific Corporation · May 2017
VAMP Venous/Arterial Blood Management Protection System
K161962 · Edwards Lifesciences, LLC · Nov 2016
CXI Support Catheter
K160884 · Cook Incorporated · Nov 2016
SwiftNINJA Microcatheter
K161921 · Merit Medical Systems, Inc. · Nov 2016