DXF · Product Code · Chrysalis Intelligence

Device class

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Regulation —

Total clearances

2021-07-19 → 2026-06-26

Last 12 months

Unique sponsors

Classification details

Medical specialty

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Review panel

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Regulation number

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Implant

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Life-sustain / support

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GMP exempt

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Third-party review

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Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor	Clearances	Last 12 mo	Most recent
Circa Scientific, Inc.	3	0	2025-05-01
Atraverse Medical, Inc.	3	1	2026-02-27
Pressure Products Medical Device Manufacturing, LLC	1	1	2026-03-13
Cross Vascular, Inc.	1	0	2023-10-12
Baylis Medical Company	1	0	2024-11-01
NuMED, Inc.	1	0	2021-07-19
ElectroWire Medical	1	1	2026-06-26
Edwards Lifesciences, LLC	1	0	2022-08-22

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
93580	CPT	—	High	Percutaneous transcatheter septal reduction (includes balloon dilation and/or alcohol septal ablation when performed)

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-06-26	K261745	ElectroWire Medical	LightningWire Transseptal Puncture System (TPS)
2026-03-13	K253799	Pressure Products Medical Device Manufacturing, LLC	SafeSept RF Transseptal Guidewire (SSRF132; SSRF132R; SSRF232; SSRF232R; SSRF135; SSRF135R; SSRF235; SSRF235R)
2026-02-27	K260292	Atraverse Medical	HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX)
2025-08-27	K252419	Atraverse Medical, Inc.	HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX)
2025-05-01	K251007	Circa Scientific, Inc.	CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C, CW-1085C, CW-1085V, CW-1013F)
2024-11-26	K243193	Circa Scientific, Inc.	Cross Wise Multi-Use RF Adapter Cable
2024-11-01	K242076	Baylis Medical Company	VersaCross RF Wire
2024-09-26	K241414	Circa Scientific, Inc.	CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C); CrossWise RF Adapter Cable (Model CW-1002)
2024-05-01	K240900	Atraverse Medical	HOTWIRE RF Guidewire
2023-10-12	K232852	Cross Vascular, Inc.	Cross Vascular RF Transseptal Needle, Cross Vascular Connection Cable
2022-08-22	K221528	Edwards Lifesciences, LLC	Fogarty Dilation Atrioseptostomy Catheter, Miller Balloon Atrioseptostomy Catheter
2021-07-19	K211910	NuMED, Inc.	Z-6 Atrioseptostomy Catheter

DXF · Unclassified

Clearance volume by quarter

Top sponsors in this product code

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

Most recent 510(k) clearances