KRA · Catheter, Continuous Flush · Chrysalis Intelligence

Device class

Class II

Regulation 870.1210

Total clearances

2020-04-21 → 2026-09-21

Last 12 months

Unique sponsors

Classification details

Medical specialty

Cardiovascular

Review panel

Regulation number

870.1210

Implant

Life-sustain / support

GMP exempt

Third-party review

Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor	Clearances	Last 12 mo	Most recent
Merit Medical Systems, Inc.	3	0	2021-07-16
Instylla, Inc.	3	1	2026-06-11
Balt USA, LLC	2	0	2022-07-19
SmartWise Sweden AB	2	1	2026-09-11
Trisalus Life Sciences	2	1	2026-09-21
Medos International SARL	2	0	2022-04-12
Boston Scientific Corporation	2	1	2026-05-15
Mercator Medsystems, Inc.	1	0	2021-08-02
Wallaby Medical	1	0	2023-04-25
Suzhou Zenith Vascular SciTech Limited	1	0	2025-07-30
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular	1	0	2020-09-14
Bend IT Technologies, Ltd.	1	0	2020-06-25
Agile Devices, Inc.	1	0	2022-01-07
Merit Medical System, Inc.	1	0	2023-03-30
Suzhou Hengrui Hongyuan Medical Co., Ltd.	1	0	2022-04-11
Vascupatent Medical (Shenzhen) Co., Ltd.	1	0	2022-11-07
Micro Therapeuatics, Inc. D/B/A Ev3 Neurovascular	1	0	2021-02-16
Ablative Solutions, Inc.	1	0	2023-07-05
Vvt Medical , Ltd.	1	0	2023-06-20
Transit Scientific, LLC	1	0	2023-11-29
Argon Medical Devices, Inc.	1	0	2023-04-10
Invera Medical	1	1	2026-03-12

Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

Code	Type	Description	Confidence	Rationale
A4210	HCPCS	Needle-free injection device, each ✓ CMS-verified description	High	Arterial puncture supplies
36000	CPT	—	Medium	Introduction of needle or intracatheter; vein
36010	CPT	—	Medium	Percutaneous arterial puncture for diagnostic purposes

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-09-21	K253509	Trisalus Life Sciences	TriSalus TriNav Advance Infusion System
2026-09-11	K254051	SmartWise Sweden AB	Extroducer Infusion Catheter System
2026-06-11	K261610	Instylla, Inc.	Verge Microcatheter
2026-05-15	K260771	Boston Scientific Corporation	TruSelect 2.6 Microcatheter
2026-03-12	K250794	Invera Medical	InVera Infusion Device
2025-07-30	K243534	Suzhou Zenith Vascular SciTech Limited	Micro Catheter
2023-11-29	K231821	Transit Scientific, LLC	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,)
2023-07-05	K231279	Ablative Solutions, Inc.	Peregrine System Infusion Catheter 4-7 mm, Peregrine System Infusion Catheter 3-4 mm
2023-06-20	K231148	Vvt Medical , Ltd.	ScleroSafe 150 mm, ScleroSafe 350 mm
2023-05-02	K230957	Trisalus Life Sciences	TriSalus TriNav® LV Infusion System
2023-04-25	K223139	Wallaby Medical	Wallaby 017 Micro Catheter
2023-04-10	K223176	Argon Medical Devices, Inc.	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
2023-03-30	K230636	Merit Medical System, Inc.	Maestro Microcatheter
2022-11-07	K222679	Vascupatent Medical (Shenzhen) Co., Ltd.	Vericor Support Catheter
2022-07-19	K213435	Balt USA, LLC	MAGIC Flow-Dependent Microcatheter
2022-06-10	K213442	SmartWise Sweden AB	Extroducer Infusion Catheter System
2022-04-12	K214025	Medos International SARL	PROWLER SELECT LP ES Microcatheter; PROWLER XS Microcatheter
2022-04-11	K212719	Suzhou Hengrui Hongyuan Medical Co., Ltd.	Micro Catheter and Guidewire System
2022-01-07	K211110	Agile Devices, Inc.	Agile Devices Angler Steerable, Deflectable Microcatheter
2021-08-25	K210838	Medos International SARL	PROWLER SELECT PLUS; PROWLER EX
2021-08-02	K210339	Mercator Medsystems, Inc.	Bullfrog Micro-Infusion Device
2021-07-16	K211525	Merit Medical Systems, Inc.	SwiftNINJA Steerable Microcatheter
2021-04-15	K210808	Instylla, Inc.	Instylla Microcatheter 1.2
2021-02-16	K210114	Micro Therapeuatics, Inc. D/B/A Ev3 Neurovascular	Rebar Micro Catheter
2021-01-29	K202366	Balt USA, LLC	MAGIC Infusion Catheter