DQX · Wire, Guide, Catheter · Chrysalis Intelligence

Device class

Class II

Regulation 870.1330

Total clearances

2020-01-02 → 2026-09-18

Last 12 months

Unique sponsors

Classification details

Medical specialty

Cardiovascular

Review panel

Regulation number

870.1330

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
Asahi Intecc Co., Ltd.	11	0	2025-04-02
Filmecc Co., Ltd.	6	1	2026-09-03
Merit Medical Ireland, Ltd.	5	4	2026-07-13
Lake Region Medical	4	1	2026-03-19
ABBOTT MEDICAL	3	0	2025-10-03
Volcano Corporation	3	0	2021-04-15
Opsens, Inc.	3	0	2024-05-24
Merit Medical Systems, Inc.	3	0	2024-12-10
Vascular Solutions, LLC	3	0	2023-05-05
FMD Co., Ltd.	3	1	2026-03-20
Biomerics Nle	2	0	2024-05-14
Baylis Medical Company, Inc.	2	0	2023-03-01
William Cook Europe Aps	2	1	2025-11-09
Abbott Vascular	2	0	2020-07-30
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular	2	0	2020-07-21
Terumo Corporation	2	0	2024-11-26
Filmec Co. , Ltd.	2	0	2023-10-11
Cardio Flow Inc.,	1	0	2022-03-18
Scientia Vascular, LLC	1	0	2020-07-29
Teleflex Medical	1	0	2024-09-18
Spartan Micro, Inc.	1	0	2022-04-19
Rapid-Medical , Ltd.	1	1	2026-09-18
Nano4imaging GmbH	1	1	2026-03-06
Suzhou Hengrui Disheng Medical Co., Ltd.	1	0	2020-08-26
Seven Sons , Ltd.	1	0	2022-08-19

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
36568	CPT	—	Medium	Guide wire is typically bundled into catheterization procedure codes
92004	CPT	—	Low	May be component of diagnostic catheterization

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-09-18	K253146	Rapid-Medical , Ltd.	Hyperdrive 35 Guidewire
2026-09-03	K261281	Filmecc Co., Ltd.	CROSSLEAD Standard 035 and CROSSLEAD Stiff 035
2026-07-14	K253667	Sp Medical A/S	Accoat Guide Wire
2026-07-13	K261640	Merit Medical Ireland , Ltd.	Merit MAK Nitinol/Gold-Tungsten Guide Wire
2026-05-22	K254137	Merit Medical Ireland, Ltd.	InQwire Amplatz Guide Wire
2026-03-20	K260544	FMD Co., Ltd.	FMD Peripheral Guide Wire F-14 Flex 6; FMD Peripheral Guide Wire F-14 Tapered 40; FMD Peripheral Guide Wire F-18 Flex SP; FMD Peripheral Guide Wire F-18 DP 25; FMD Peripheral Guide Wire F-18 Tapered 40
2026-03-19	K253746	Lake Region Medical	Enroute 0.014'' Transcarotid Guidewire
2026-03-06	K253262	Nano4imaging GmbH	EmeryGlide (EG18008901)
2026-01-31	K253847	Merit Medical Ireland, Ltd.	Splashwire Hydrophilic Guide Wire (MSWSTD35150J3)
2026-01-21	K251385	Merit Medical Ireland, Ltd.	InQwire Super Stiff Guide Wire (IQSS32180J3); InQwire Super Stiff Guide Wire (IQSS35F260S); InQwire Super Stiff Guide Wire (IQSS35F150S); InQwire Super Stiff Guide Wire (IQSS35F100S); InQwire Super Stiff Guide Wire (IQSS35F80S); InQwire Super Stiff Guide Wire (IQSS35F180S)
2026-01-09	K252674	Solo Pace, Inc.	Solo Pace Fusion System (SOLOFUSE1)
2025-11-09	K251596	William Cook Europe Aps	Lunderquist Extra Stiff Wire Guide
2025-10-17	K250203	Sureax Medical, LLC	SureAx-Guide
2025-10-03	K250031	ABBOTT MEDICAL	Amplatzer Guidewire
2025-08-29	K251181	Merit Medical Ireland, Ltd.	Splashwire Hydrophilic Guide Wire (MSWSTD35180J1O5); Splashwire Hydrophilic Guide Wire (MSWSTD35260J1O5); Splashwire Hydrophilic Guide Wire (MSWSTDA35150LT); Splashwire Hydrophilic Guide Wire (MSWSTFA35260LT); Splashwire Hydrophilic Guide Wire (MSWSTFA35150LT); Splashwire Hydrophilic Guide Wire (MSWSTFS38150LT)
2025-07-25	K250552	ABBOTT MEDICAL	Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire
2025-06-13	K250075	Medtronic, Inc.	Medtronic Stedi Extra Support Guidewire
2025-04-02	K243733	Asahi Intecc Co., Ltd.	SION blue PLUS
2025-03-27	K241962	Asahi Intecc Co., Ltd.	Crossloop
2025-03-05	K242597	Asahi Intecc Co., Ltd.	CROSSLEAD 0.018inch
2025-02-06	K241702	Asahi Intecc Co., Ltd.	CROSSLEAD 0.014inch
2024-12-10	K241521	Merit Medical Systems, Inc.	Prelude Small O.D. Introducer Guide Wire
2024-12-06	K242824	Lake Region Medical	PTFE Guidewire
2024-11-26	K240818	Terumo Corporation	R2P Radifocus Glidewire Advantage
2024-11-06	K240997	ABBOTT MEDICAL	Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire