Chrysalis Intelligence · Product Codes · NTE

NTE · Unclassified

5 clearances · 4 unique sponsors

Device class
Regulation —
Total clearances
5
2020-03-18 → 2023-04-27
Last 12 months
0
Unique sponsors
4
Medical specialty
Review panel
Regulation number
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
Cardiovascular Systems, Inc. 2 0 2021-03-03
MicroVention, Inc. 1 0 2023-04-27
Silk Road Medical 1 0 2023-04-11
Cordis Corporation 1 0 2022-04-06
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