Chrysalis Intelligence · Product Codes · KRA

KRA · Unclassified

29 clearances · 22 unique sponsors

Device class
Regulation —
Total clearances
29
2020-04-21 → 2026-06-11
Last 12 months
3
Unique sponsors
22
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
Merit Medical Systems, Inc. 3 0 2021-07-16
Instylla, Inc. 3 1 2026-06-11
Medos International SARL 2 0 2022-04-12
Balt USA, LLC 2 0 2022-07-19
Boston Scientific Corporation 2 1 2026-05-15
Suzhou Hengrui Hongyuan Medical Co., Ltd. 1 0 2022-04-11
Mercator Medsystems, Inc. 1 0 2021-08-02
Suzhou Zenith Vascular SciTech Limited 1 0 2025-07-30
Vascupatent Medical (Shenzhen) Co., Ltd. 1 0 2022-11-07
Bend IT Technologies, Ltd. 1 0 2020-06-25
Agile Devices, Inc. 1 0 2022-01-07
Merit Medical System, Inc. 1 0 2023-03-30
Transit Scientific, LLC 1 0 2023-11-29
Trisalus Life Sciences 1 0 2023-05-02
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular 1 0 2020-09-14
SmartWise Sweden AB 1 0 2022-06-10
Ablative Solutions, Inc. 1 0 2023-07-05
Vvt Medical , Ltd. 1 0 2023-06-20
Invera Medical 1 1 2026-03-12
Micro Therapeuatics, Inc. D/B/A Ev3 Neurovascular 1 0 2021-02-16
Wallaby Medical 1 0 2023-04-25
Argon Medical Devices, Inc. 1 0 2023-04-10
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
A4210 HCPCS Needle-free injection device, each ✓ CMS-verified description High Arterial puncture supplies
36000 CPT Medium Introduction of needle or intracatheter; vein
36010 CPT Medium Percutaneous arterial puncture for diagnostic purposes
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-06-11 K261610 Instylla, Inc. Verge™ Microcatheter
2026-05-15 K260771 Boston Scientific Corporation TruSelect™ 2.6 Microcatheter
2026-03-12 K250794 Invera Medical InVera Infusion Device
2025-07-30 K243534 Suzhou Zenith Vascular SciTech Limited Micro Catheter
2023-11-29 K231821 Transit Scientific, LLC XO Cath Microcatheter (E20-090-S, E20-110-S, E20-130-S, E20-150-S, E20-175-S, E20-220-S, E20-090-B, E20-110-B, E20-130-B, E20-150-B, E20-175-B, E20-220-B, E26-090-S, E26-110-S, E26-130-S, E26-150-S, E26-175-S, E26-220-S, E26-090-B, E26-110-B, E26-130-B, E26-150-B, E26-175-B, E26-220-B,)
2023-07-05 K231279 Ablative Solutions, Inc. Peregrine System Infusion Catheter 4-7 mm, Peregrine System Infusion Catheter 3-4 mm
2023-06-20 K231148 Vvt Medical , Ltd. ScleroSafe™ 150 mm, ScleroSafe™ 350 mm
2023-05-02 K230957 Trisalus Life Sciences TriSalus TriNav® LV Infusion System
2023-04-25 K223139 Wallaby Medical Wallaby 017 Micro Catheter
2023-04-10 K223176 Argon Medical Devices, Inc. Cleaner Plus™ Thrombectomy System, Cleaner Plus™ Aspiration Catheter, Cleaner Plus™ Handpiece with 65cm Maceration Wire, Cleaner Plus™ Handpiece with 135cm Maceration Wire, Cleaner Plus™ Aspiration Canister
2023-03-30 K230636 Merit Medical System, Inc. Maestro Microcatheter
2022-11-07 K222679 Vascupatent Medical (Shenzhen) Co., Ltd. Vericor Support Catheter
2022-07-19 K213435 Balt USA, LLC MAGIC Flow-Dependent Microcatheter
2022-06-10 K213442 SmartWise Sweden AB Extroducer Infusion Catheter System
2022-04-12 K214025 Medos International SARL PROWLER SELECT LP ES Microcatheter; PROWLER XS Microcatheter
2022-04-11 K212719 Suzhou Hengrui Hongyuan Medical Co., Ltd. Micro Catheter and Guidewire System
2022-01-07 K211110 Agile Devices, Inc. Agile Devices Angler Steerable, Deflectable Microcatheter
2021-08-25 K210838 Medos International SARL PROWLER SELECT PLUS; PROWLER EX
2021-08-02 K210339 Mercator Medsystems, Inc. Bullfrog Micro-Infusion Device
2021-07-16 K211525 Merit Medical Systems, Inc. SwiftNINJA Steerable Microcatheter
2021-04-15 K210808 Instylla, Inc. Instylla Microcatheter 1.2
2021-02-16 K210114 Micro Therapeuatics, Inc. D/B/A Ev3 Neurovascular Rebar Micro Catheter
2021-01-29 K202366 Balt USA, LLC MAGIC Infusion Catheter
2020-09-14 K202318 Micro Therapeutics, Inc. d/b/a ev3 Neurovascular Marathon Flow Directed Micro Catheter
2020-08-07 K193082 Merit Medical Systems, Inc. Fountain ValveTip Infusion Catheter