The following data is part of a premarket notification filed by Cardiovascular Systems Incorporated with the FDA for Orbital Atherectomy System For Treatment Of A-v Shunt Stenosis.
| Device ID | K041630 |
| 510k Number | K041630 |
| Device Name: | ORBITAL ATHERECTOMY SYSTEM FOR TREATMENT OF A-V SHUNT STENOSIS |
| Classification | Catheter, Peripheral, Atherectomy |
| Applicant | CARDIOVASCULAR SYSTEMS INCORPORATED 800 LEVANGER LANE Stoughton, WI 53589 |
| Contact | Gary Syring |
| Correspondent | Gary Syring CARDIOVASCULAR SYSTEMS INCORPORATED 800 LEVANGER LANE Stoughton, WI 53589 |
| Product Code | MCW |
| CFR Regulation Number | 870.4875 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-06-16 |
| Decision Date | 2005-01-31 |
| Summary: | summary |