FDA Product Code KRA: Catheter, Continuous Flush
FDA product code KRA covers continuous flush catheters used for hemodynamic pressure monitoring.
These catheters incorporate a slow continuous infusion mechanism that maintains line patency and prevents thrombus formation in arterial pressure monitoring lines and pulmonary artery catheters. They deliver a controlled flush rate of 3 mL/hour without requiring manual flushing.
KRA devices are Class II medical devices, regulated under 21 CFR 870.1210 and reviewed by the FDA Cardiovascular panel.
Leading manufacturers include Boston Scientific Corp, Merit Medical Systems, Inc. and Baxter Healthcare Corp.
174
Total
174
Cleared
122d
Avg days
1977
Since
Declining activity -
3 submissions in the last 2 years
vs 9 in the prior period
Review times increasing: avg
229d
recently vs 120d historically
FDA 510(k) Cleared Catheter, Continuous Flush Devices (Product Code KRA)
174 devices
Cleared
May 15, 2026
TruSelect™ 2.6 Microcatheter
Boston Scientific Corporation
Cardiovascular
67d
Cleared
Mar 12, 2026
InVera Infusion Device
Invera Medical
Cardiovascular
363d
Cleared
Jul 30, 2025
Micro Catheter
Suzhou Zenith Vascular SciTech Limited
Neurology
257d
Cleared
Nov 29, 2023
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,)
Transit Scientific, LLC
Cardiovascular
161d
Cleared
Jul 05, 2023
Peregrine System Infusion Catheter 4-7 mm, Peregrine System Infusion Catheter 3-4 mm
Ablative Solutions, Inc.
Cardiovascular
63d
Cleared
Jun 20, 2023
ScleroSafe™ 150 mm, ScleroSafe™ 350 mm
Vvt Medical , Ltd.
Cardiovascular
60d
Cleared
May 02, 2023
TriSalus TriNav® LV Infusion System
Trisalus Life Sciences
Cardiovascular
28d
Cleared
Apr 25, 2023
Wallaby 017 Micro Catheter
Wallaby Medical
Neurology
203d
Cleared
Apr 10, 2023
Cleaner Plus™ Thrombectomy System, Cleaner Plus™ Aspiration Catheter, Cleaner Plus™ Handpiece with 65cm Maceration Wire, Cleaner Plus™ Handpiece with 135cm Maceration Wire, Cleaner Plus™ Aspiration Canister
Argon Medical Devices, Inc.
Cardiovascular
181d
Cleared
Mar 30, 2023
Maestro Microcatheter
Merit Medical System, Inc.
Cardiovascular
23d
Cleared
Nov 07, 2022
Vericor Support Catheter
Vascupatent Medical (Shenzhen) Co., Ltd.
Cardiovascular
62d
Cleared
Jul 19, 2022
MAGIC Flow-Dependent Microcatheter
Balt USA, LLC
Neurology
270d
Cleared
Jun 10, 2022
Extroducer Infusion Catheter System
SmartWise Sweden AB
Cardiovascular
228d
Cleared
Apr 12, 2022
PROWLER SELECT LP ES Microcatheter
Medos International SARL
Neurology
111d
Cleared
Apr 11, 2022
Micro Catheter and Guidewire System
Suzhou Hengrui Hongyuan Medical Co., Ltd.
Cardiovascular
227d
Cleared
Jan 07, 2022
Agile Devices Angler Steerable, Deflectable Microcatheter
Agile Devices, Inc.
Cardiovascular
268d
Cleared
Aug 25, 2021
PROWLER SELECT PLUS
Medos International SARL
Neurology
156d
Cleared
Aug 02, 2021
Bullfrog Micro-Infusion Device
Mercator Medsystems, Inc.
Cardiovascular
178d
Cleared
Jul 16, 2021
SwiftNINJA Steerable Microcatheter
Merit Medical Systems, Inc.
Cardiovascular
60d
Cleared
Apr 15, 2021
Instylla Microcatheter 1.2
Instylla, Inc.
Cardiovascular
29d
Cleared
Feb 16, 2021
Rebar Micro Catheter
Micro Therapeuatics, Inc. D/B/A Ev3 Neurovascular
Neurology
28d
Cleared
Jan 29, 2021
MAGIC Infusion Catheter
Balt USA, LLC
Neurology
163d
Cleared
Sep 14, 2020
Marathon Flow Directed Micro Catheter
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
Neurology
28d
Cleared
Aug 07, 2020
Fountain ValveTip Infusion Catheter
Merit Medical Systems, Inc.
Cardiovascular
276d
About Product Code KRA - Regulatory Context
510(k) Submission Activity
174 total 510(k) submissions under product code KRA since 1977, with 174 receiving FDA clearance (average review time: 122 days).
Submission volume has declined in recent years - 3 submissions in the last 24 months compared to 9 in the prior period.
FDA 510(k) Review Time - KRA Product Code
Recent submissions under KRA have taken an average of 229 days to reach a decision - up from 120 days historically. Manufacturers should account for longer review timelines in current project planning.
KRA devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →