FDA Registration
Active
🇺🇸 United States
Cardiovascular Systems Incorporated
Reg #: 3004742232
·
FEI: 3004742232
·
Expires 2026
Products
5
Proprietary Names
21
Establishment Types
4
Classifications
5
Registration Details
- Registration Name
- Cardiovascular Systems Incorporated
- Registration Number
- 3004742232
- FEI Number
- 3004742232
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1225 Old Highway 8 NW
- City
- Saint Paul
- State
- MN
- ZIP
- 55112
- Country
- US
Regulatory Submissions
- 510(k) Number
- K220568
- PMA Number
- P130005
Owner / Operator
- Firm Name
- ABBOTT LABORATORIES
- Operator Number
- 1415939
- Address
- 100 ABBOTT PARK RD., D-03Q3, AP52-1
- City
- Abbott Park
- State
- IL
- Postal Code
- 60064
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Tape, Measuring, Rulers And Calipers | FTY | Class 1 | General, Plastic Surgery | No | 2008-09-19 |
| Catheter, Peripheral, Atherectomy | MCW | Class 2 | Cardiovascular | No | 2022-07-14 |
| Catheter, Percutaneous | DQY | Class 2 | Cardiovascular | No | 2021-08-30 |
| Temporary Carotid Catheter For Embolic Capture | NTE | Class 2 | Cardiovascular | No | 2021-03-04 |
| Catheter, Coronary, Atherectomy | MCX | Class 3 | Unknown | No | 2013-10-28 |
Proprietary Names
ViperTrack
20 Max Crown
Diamondback 360® Peripheral Orbital Atherectomy
Stealth 360 PAD System
Stealth OAS
Diamondback OAS
Diamondback
ViperCross Support Catheters
DIAMONDBACK 360 Peripheral Orbital Atherectomy System
Diamondback Peripheral Micro
ViperSlide Lubricant
Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series
VIPERWIRE ADVANCE with FLEXTIP Peripheral Atherectomy Guidewire
ViperCath XC Peripheral Exchange Catheter
WIRION Embolic Protection System
DiamondBack 360 Peripheral Orbital Atherectomy System, Exchangeable
Stealth 360 Peripheral Orbital Atherectomy System
DiamondBack 360 Peripheral Orbital Atherectomy System
Viperwire Advance with Flextip
WIRION
DIAMONDBACK 360 Coronary Orbital Atherectomy System
Establishment Types
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device