ACIST ANTIOGRAPHIC INJECTION SYSTEM CONTRAST MANAGEMENT DISPOSABLE KITS
FDA 510(k) clearance K040298 · decided 2004-03-15
Clearance details
- K-number
- K040298
- Device name
- ACIST ANTIOGRAPHIC INJECTION SYSTEM CONTRAST MANAGEMENT DISPOSABLE KITS
- Applicant
- Acist Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-02-09
- Decision date
- 2004-03-15
- Days to decision
- 35 days
- Clearance type
- Special
- 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 Medical Systems Inc. The ACIST Angiographic Injection System is intended to be used recall (Z-1145-2013) | Acist Medical Systems | 2013-04-18 |
| ACIST Automated Manifold Kit , REF Model BT2000, SKU # 014613, Sterile R, Made in Mexico, recall (Z-1872-2009) | Acist Medical Systems | 2009-08-30 |
| ACIST" BRACCO, AT P54 AngioTouch Kit , SKU # 014644, Sterile EO Manufacturer; ACTB Medical recall (Z-2406-2008) | Acist Medical Systems | 2008-09-23 |