DYG · Catheter, Flow Directed · Chrysalis Intelligence

Device class

Class II

Regulation 870.1240

Total clearances

2020-02-16 → 2024-12-09

Last 12 months

Unique sponsors

Classification details

Medical specialty

Cardiovascular

Review panel

Regulation number

870.1240

Implant

Life-sustain / support

GMP exempt

Third-party review

Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor	Clearances	Most recent
Edwards Lifesciences	4	2024-12-09
Edwards Lifesiences, LLC	1	2022-12-09
Edwards Lifesciencess, LLC	1	2023-09-21

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
93503	CPT	—	High	Flow-directed catheter insertion for hemodynamic monitoring, standard cardiovascular procedure
93505	CPT	—	Medium	Alternative CPT for catheter placement depending on vessel access and clinical context

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2024-12-09	K242451	Edwards Lifesciences	HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta- monitor pressure cable (HEMAPSC200);Acumen AFM cable- HemoSphere Alta monitor (HEMAFM100)
2024-06-27	K233983	Edwards Lifesciences	Swan-Ganz Pacing Probe and Catheters; Swan-Ganz Bipolar Pacing Catheter (D97120F5); Swan-Ganz Bipolar Pacing Catheter (D97130F5); Swan-Ganz Pacing Thermodilution TD Catheter (D200F7); Chandler Transluminal V-Pacing Probe (D98100)
2024-06-06	K233824	Edwards Lifesciences, LLC	Swan-Ganz catheter
2023-09-21	K231248	Edwards Lifesciencess, LLC	Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced Monitoring Platform
2022-12-09	K222117	Edwards Lifesiences, LLC	Swang-Ganz IQ pulmonary artery catheter
2020-02-16	K193466	Edwards Lifesciences, LLC	Swan-Ganz Catheters