Chrysalis Intelligence · Product Codes · NTE

NTE · Temporary Carotid Catheter For Embolic Capture

Cardiovascular · 5 clearances · 4 unique sponsors

Device class
Class II
Regulation 870.1250
Total clearances
5
2020-03-18 → 2023-04-27
Last 12 months
0
Unique sponsors
4
Definition

What is Temporary Carotid Catheter For Embolic Capture

This device is a single use percutaneous catheter system that is introduced into an artery through the skin using a guidewire. The catheter has an embolic capture filter or an occlusion balloon at the distal end. The filter or balloon can be placed either distally to the lesion or proximally depending on the design of the device and intended use. The filter or balloon is used to capture embolic material in a manner that may protect or prevent a stroke or other cerebral vascular sequelae. The embolic capture device is indicated for use as a guidewire and embolic protection system to contain and remove embolic material (thrombus/debris) while performing angioplasty and stenting procedures i
Medical specialty
Cardiovascular
Review panel
CV
Regulation number
870.1250
Implant
N
Life-sustain / support
N
GMP exempt
N
Third-party review
N
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Cardiovascular Systems, Inc. 2 0 2021-03-03
MicroVention, Inc. 1 0 2023-04-27
Cordis Corporation 1 0 2022-04-06
Silk Road Medical 1 0 2023-04-11
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.

CodeTypeDescriptionConfidenceRationale
61645 CPT — High Thrombus retrieval with embolic capture filter/balloon during carotid intervention for stroke
37184 CPT — Medium Percutaneous endovascular revascularization with embolic protection device in extracranial carotid
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2023-04-27 K222694 MicroVention, Inc. EmPro EPS (EP4514C-190, EP6514C-190);Nanoparasol EPS (PNP4514C-190,PNP6514C-190)
2023-04-11 K230402 Silk Road Medical ENROUTE® Transcarotid Neuroprotection System
2022-04-06 K220654 Cordis Corporation ANGIOGUARD XP Emboli Capture Guidewire, ANGIOGUARD RX Emboli Capture Guidewire
2021-03-03 K210282 Cardiovascular Systems, Inc. WIRION Embolic Protection System
2020-03-18 K200198 Cardiovascular Systems, Inc. WIRION