DRA · Catheter, Steerable · Chrysalis Intelligence

Device class

Class II

Regulation 870.1280

Total clearances

2020-11-13 → 2026-07-24

Last 12 months

Unique sponsors

Classification details

Medical specialty

Cardiovascular

Review panel

Regulation number

870.1280

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
Boston Scientific Corporation	3	1	2026-07-24
Acutus Medical, Inc.	2	0	2022-05-05
ABBOTT MEDICAL	1	0	2022-09-28
Medtronic Cryocath, LP	1	0	2020-11-13
Kardium, Inc.	1	0	2025-06-03
Medtronic, Inc.	1	0	2023-10-31

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	Steerable catheter typically used in diagnostic or interventional catheterization
93566	CPT	—	Medium	Alternative code for cardiac catheterization with pullback recordings

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-07-24	K262165	Boston Scientific Corporation	FARADRIVE Steerable Sheath (M004PF21M402)
2025-06-03	K250529	Kardium, Inc.	Globe Introducer (601-01001)
2023-12-11	K233248	Boston Scientific Corporation	FARADRIVE Steerable Sheath
2023-10-31	K232321	Medtronic, Inc.	FlexCath Contour Steerable Sheath
2023-03-22	K223824	Boston Scientific Corporation	POLARSHEATH Steerable Sheath 12F (UPN:M004CRBS3150), POLARMAP Circular Mapping Catheter (UPN:M004CRBS7210), POLARMAP EP Electrical Cable (UPN:M004CRBS62000), SMARTFREEZE Esophageal Temperature Sensor (ETS) Cable: -SMARTFREEZE Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6310), -SMARTFREEZE 16 PIN Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6320), -SMARTFREEZE CIRCA Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6340), SMARTFREEZE Pressure Sensor
2022-09-28	K221397	ABBOTT MEDICAL	MitraClip G4 Steerable Guide Catheter
2022-05-05	K221044	Acutus Medical, Inc.	AcQGuide® VUE Steerable Sheath
2021-05-14	K211100	Acutus Medical, Inc.	AcQGuide MAX Steerable Sheath
2020-11-13	K202620	Medtronic Cryocath, LP	FlexCath Advance Steerable Sheath and Dilator