C2000 AUTOMATED MANIFOLD KIT
FDA 510(k) clearance K052744 · decided 2005-12-16
Clearance details
- K-number
- K052744
- Device name
- C2000 AUTOMATED MANIFOLD KIT
- Applicant
- Acist Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-09-30
- Decision date
- 2005-12-16
- Days to decision
- 77 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, BT2000 Automated Manifold Kit (SKU 014613) and CPT2000 (SKU 014623) recall (Z-0744-2016) | Acist Medical Systems | 2016-02-02 |