DXE · Product Code · Chrysalis Intelligence

Device class

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Regulation —

Total clearances

2020-06-12 → 2024-08-28

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	Most recent
Edwards Lifesciences	6	2024-08-28
Applied Medical Resources Corporation	1	2021-09-07
Mivi Neurovascular, Inc.	1	2022-01-27

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
37184	CPT	—	High	Percutaneous transluminal mechanical thrombectomy and/or infusion for thrombolysis, noncoronary occlusion

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2024-08-28	K240078	Edwards Lifesciences, LLC	Fogarty Thru-Lumen Embolectomy Catheter
2024-07-02	K241330	Edwards Lifesciences	Fogarty Fortis Arterial Embolectomy Catheter
2024-05-22	K233820	Edwards Lifesciences	Fogarty Arterial Embolectomy Catheter with Gate Valve
2024-05-22	K233819	Edwards Lifesciences, LLC	Fogarty Venous Thrombectomy Catheters
2024-05-20	K233619	Edwards Lifesciences	Fogarty Corkscrew Catheters; Fogarty Graft Thrombectomy Catheters
2022-01-27	K213771	Mivi Neurovascular, Inc.	Merlin Aspiration System
2021-09-07	K202049	Applied Medical Resources Corporation	Python Catheter/Over-the-Wire Latis Graft Cleaning Catheter
2020-06-12	K193379	Edwards Lifesciences, LLC	Fogarty Arterial Embolectomy Catheter, Fogarty Biliary Balloon Probe

DXE · Unclassified

Clearance volume by quarter

Top sponsors in this product code

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

Most recent 510(k) clearances