MODIFICATION TO ACIST CL 100H
FDA 510(k) clearance K991103 · decided 2000-05-31
Clearance details
- K-number
- K991103
- Device name
- MODIFICATION TO ACIST CL 100H
- Applicant
- Acist Medical Systems
- Decision
- Substantially Equivalent
- Date received
- 1999-04-01
- Decision date
- 2000-05-31
- Days to decision
- 426 days
- Clearance type
- Traditional
- Product code
- DXT
- Device class
- 2
- Regulation number
- 870.1650
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Eden Prairie, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ACIST CVi Angiographic Injection System with Interface Cable for Toshiba Infinix-i cardiov recall (Z-0643-2009) | Acist Medical Systems | 2009-01-08 |
| AngioTouch Kit Model H1000P Hand Controller kits used with the ACIST Contrast Management S recall (Z-1002-04) | Acist Medical Systems | 2004-07-20 |
| ACIST Automated Manifold (Transducer) Kit, Model BT2000, SKU #014613 (used with ACIST Cont recall (Z-0064-04) | Acist Medical Systems | 2003-10-24 |