Chrysalis Intelligence · Product Codes · MJN

MJN · Unclassified

13 clearances · 11 unique sponsors

Device class
Regulation —
Total clearances
13
2020-01-09 → 2025-09-05
Last 12 months
1
Unique sponsors
11
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
Prytime Medical Devices, Inc. 3 1 2025-09-05
Renovorx, Inc. 1 0 2021-08-23
Renalpro Medical, Inc. 1 0 2021-07-09
Edwards Lifesciences, LLC 1 0 2022-02-14
Abiomed, Inc. 1 0 2023-06-30
Spectranetics, Inc. 1 0 2020-12-23
Philips Image Guided Therapy Devices 1 0 2025-06-24
Neurescue Aps 1 0 2021-05-21
Arch Catheter, LLC 1 0 2020-04-25
Front Line Medical Technologies, Inc. 1 0 2021-02-22
Zien Medical Technologies, Inc. 1 0 2022-09-19
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
37204 CPT Medium CPT for vascular intervention; occluding catheter placement in intravascular procedures
37241 CPT Medium CPT for vascular occlusion; temporary intravascular occlusion procedure code
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2025-09-05 K243795 Prytime Medical Devices, Inc. pREBOA-PRO Catheter
2025-06-24 K251358 Philips Image Guided Therapy Devices Bridge Plus Occlusion Balloon (590-002)
2023-06-30 K221294 Abiomed, Inc. preCARDIA Occlusion System
2022-09-19 K214060 Zien Medical Technologies, Inc. LANDMARK REBOA Catheter
2022-02-14 K211610 Edwards Lifesciences, LLC Fogarty Occlusion Catheter
2021-08-23 K212324 Renovorx, Inc. RenovoCath
2021-07-09 K210602 Renalpro Medical, Inc. AortaSTAT Occlusion Device
2021-05-21 K210358 Neurescue Aps Neurescue device
2021-02-22 K201652 Front Line Medical Technologies, Inc. COBRA-OS Kit
2020-12-23 K203540 Spectranetics, Inc. Bridge Occlusion Balloon
2020-06-03 K200459 Prytime Medical Devices, Inc. pREBOA-PRO Catheter
2020-04-25 K192786 Arch Catheter, LLC Gatekeeper Balloon Catheter
2020-01-09 K193440 Prytime Medical Devices, Inc. ER-REBOA PLUS Catheter