Cleared Traditional

CANTATA(R) 2.9 MICROCATHETER

K131772 · Cook, Inc. · Cardiovascular
Feb 2014
Decision
248d
Days
Class 2
Risk

About This 510(k) Submission

K131772 is an FDA 510(k) clearance for the CANTATA(R) 2.9 MICROCATHETER, a Catheter, Continuous Flush (Class II — Special Controls, product code KRA), submitted by Cook, Inc. (Bloomington, US). The FDA issued a Cleared decision on February 20, 2014, 248 days after receiving the submission on June 17, 2013. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1210.

Submission Details

510(k) Number K131772 FDA.gov
FDA Decision Cleared SESE
Date Received June 17, 2013
Decision Date February 20, 2014
Days to Decision 248 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code KRA — Catheter, Continuous Flush
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1210

Similar Devices — KRA Catheter, Continuous Flush

All 172
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