KRAClass II

Catheter, Continuous Flush

21 CFR 870.1210 / Cardiovascular

KRA is the FDA product code for Catheter, Continuous Flush, a class II device type, regulated under 21 CFR 870.1210. As of 2026-09-10, FDA records hold 175 510(k) clearances under this code, the most recent dated 2026-06-11, and 96 recalls.

Classification record

Product code: KRA
Device name: Catheter, Continuous Flush
Regulation: 21 CFR 870.1210
Device class: Class II
Review panel: Cardiovascular
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: Yes
Ingested clearances: 177
Ingested recalls: 96

Clearances, product code KRA

By decision year

177 clearances under product code KRA with a decision year between 1977 and 2026, 1995 the highest year at 10.

Show the numbers

510(k) clearances under FDA product code KRA by decision year
Year	Clearances
1977	2
1978	1
1979	5
1980	2
1981	2
1983	3
1986	1
1987	1
1989	2
1990	1
1991	1
1992	1
1993	7
1994	2
1995	10
1996	9
1997	8
1998	5
1999	1
2000	5
2001	3
2002	3
2003	6
2004	6
2005	5
2006	3
2007	5
2008	7
2009	5
2010	2
2011	2
2012	3
2013	3
2014	4
2016	8
2017	4
2018	4
2019	4
2020	6
2021	6
2022	6
2023	7
2025	1
2026	5

Applicants with the most clearances

Product code KRA

Applicants holding the most 510(k) clearances under product code KRA
Applicant	Clearances
Medtronic, Inc.	17
Cordis Neurovascular, Inc.	13
Boston Scientific Corporation	12
Cook Inc.	8
Merit Medical Systems, Inc.	7
Cook Incorporated	6
Scimed Life Systems, Inc.	6
Edwards Lifesciences LLC	4
Instylla, Inc.	4
Mercator Medsystems, Inc.	4

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 117 companies shown, in name order