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Sign in to claim this brandMedical Cv, Inc.
United States·US-MF-000022350
Last updated May 23, 2026
What Medical Cv, Inc. makes
Medical Cv, Inc. manufactures cardiac annuloplasty systems, including the Northrup Universal Annuloplasty System Model 1000, which is used for mitral valve repair. The company also produces ablation devices under the AtriLaze brand, including malleable and surgical ablation probes, soft tissue ablation systems, and laser ablation systems designed for cardiac tissue modification. Additionally, they supply cardiac valve replacements, such as the Omniscience and Omnicarbon cardiac valves, intended for surgical implantation.
The company’s devices are regulated under the US Food and Drug Administration (FDA) as Class II and Class III medical devices, requiring premarket approval (PMA) or 510(k) clearance. These products are listed in the FDA’s regulatory databases, and the manufacturer is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What does Medical Cv, Inc. manufacture?
Medical Cv, Inc. produces cardiac annuloplasty systems like the Northrup Universal Annuloplasty System Model 1000 for mitral valve repair, ablation devices under the AtriLaze brand for cardiac tissue modification, and cardiac valve replacements including the Omniscience and Omnicarbon valves.
Where is Medical Cv, Inc. based?
Medical Cv, Inc. is based in the United States, as indicated by the country designation in their device registration information.
Which regulatory registries list Medical Cv, Inc.'s devices?
Medical Cv, Inc.'s devices are listed in the FDA's 510(k) clearance database and the Premarket Approval (PMA) database, reflecting their regulatory pathway for Class II and Class medical devices.
How are Medical Cv, Inc.'s devices classified?
Medical Cv, Inc.'s devices are classified as either Class II or Class III medical devices under FDA regulation, with Class II devices requiring 510(k) clearance and Class III devices requiring premarket approval (PMA).
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- United States
- Address
- 15002, North 25th Drive, Phoenix, AZ, United States
- Website
- www.icmedical.com
- —
- —
- [email protected]
- Phone
- +1 623 780 0700
- PRRC Contact
- Elena Simona Buiga
- EUDAMED SRN
- US-MF-000022350
- FDA FEI Number
- —
- DUNS Number
- —
Catalogue (200)
Page 4 of 4| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| I/A Tubing | ICM-000-0003 | FDA UDI | Class II | Active |
| Steris | SSEPEN01 | FDA UDI | Class II | Unknown |
| Non-Telescopic PenEvac® MaxReveal ™ Diamond Crystal® | ICM-000-0694 | FDA UDI | Class II | Active |
| PenEvac1 | ICM-000-0682 | FDA UDI | Class II | Active |
| Steris | SSEPEN16 | FDA UDI | Class II | Unknown |
| PenEvac1 | ICM-000-0596 | FDA UDI | Class II | Active |
| PenEvac1 | ICM-000-0583 | FDA UDI | Class II | Active |
| Non-Telescopic PenEvac | ICM-000-0678 | FDA UDI | Class II | Active |
| Electrode | ICM-000-0242 | FDA UDI | Class II | Active |
| Non-Telescopic PenEvac | ICM-000-0526 | FDA UDI | Class II | Active |
| PenEvac1®, MaxReveal ™ Diamond Crystal® | ICM-000-0702 | EUDAMEDFDA UDI | Class II | Active |
| Steris | SSEPET16 | FDA UDI | Class II | Unknown |
| RF Sensor, Shielded | ICM-000-0546 | FDA UDI | Class II | Active |
| PenEvac1 | ICM-000-0586 | FDA UDI | Class II | Active |
| Crystal Vision | ICM-470-0000 | FDA UDI | Class II | Active |
| ESU Shroud | ICM-000-0169 | EUDAMEDFDA UDI | Class II | Active |
| Crystal Vision | ICM-450-0000 | FDA UDI | Class II | Active |
| Steris | SSEPEN05 | FDA UDI | Class II | Unknown |
| I/A Tubing | 2190 | EUDAMEDFDA UDI | Class II | Active |
| Non-Telescopic PenEvac® MaxReveal ™ Diamond Crystal® | ICM-000-0710 | EUDAMEDFDA UDI | Class II | Active |
| Steris | SSEPET11 | FDA UDI | Class II | Unknown |
| Steris | SSESHR02 | FDA UDI | Class II | Unknown |
| Steris | SSEPET05 | FDA UDI | Class II | Unknown |
| Steris | SSEPEN10 | FDA UDI | Class II | Unknown |
| Steris | SSETUB02 | FDA UDI | Class II | Unknown |
| ULPA Box Filter | ICM-000-0460 | FDA UDI | Class II | Active |
| Mega Vac Plus | 2200 | FDA UDI | Class II | Unknown |
| I.c. Medical Smoke Evacuator Activator | K902611 | FDA 510(k) | Class II | Active |
| Penevac Abc Handpiece | K955020 | FDA 510(k) | Class II | Active |
| Northrup Universal Annuloplasty System, Model 1000 | K033685 | FDA 510(k) | Class II | Active |
| Si Controller Model Si 500 | K960492 | FDA 510(k) | Class II | Active |
| Telescoping Penevac | K954088 | FDA 510(k) | Class II | Active |
| Atrilaze Malleable Ablation Probe | K052495 | FDA 510(k) | Class II | Active |
| Penevac Si. | K955166 | FDA 510(k) | Class II | Active |
| Electrocautery Shroud | K953418 | FDA 510(k) | Class II | Active |
| I.c. Medical Auto Intra-Abdominal Plume Eliminator | K914118 | FDA 510(k) | Class II | Active |
| Crystal Vision | K163659 | FDA 510(k) | Class II | Active |
| Atrilaze Surgical Ablation System | K060680 | FDA 510(k) | Class II | Active |
| I.c. Medical Adjustable Direct Coupler | K900511 | FDA 510(k) | Class II | Active |
| Speculum Smoke Evacuator Tubing | K930098 | FDA 510(k) | Class II | Active |
| Laser Handpiece Shroud | K930099 | FDA 510(k) | Class II | Active |
| Atrilaze Soft Tissue Ablation System | K040744 | FDA 510(k) | Class II | Active |
| Atrilaze Mi Surgical Ablation System | K061489 | FDA 510(k) | Class II | Active |
| Crystal Vision #250d Smoke Evacuator System With Accessories | K003840 | FDA 510(k) | Class II | Active |
| Atrilaze Laser Ablation System | K081457 | FDA 510(k) | Class II | Active |
| Non-Telescopic PenEvac | K160160 | FDA 510(k) | Class II | Active |
| Crystal Vision And Accessories | K932230 | FDA 510(k) | Class II | Active |
| Electrocautery Shroud | K930097 | FDA 510(k) | Class II | Active |
| Telescoping Penevac (modification) | K961616 | FDA 510(k) | Class II | Active |
| Omniscience And Omnicarbon Cardiac Valves | P830039 | FDA PMA | Class III | Active |
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- IC Medical GmbH DE