ANGIOGRAPHIC CONTRAST MANAGEMENT SYSTEM, MODEL PART A AND PART B
FDA 510(k) clearance K984231 · decided 2000-05-31
Clearance details
- K-number
- K984231
- Device name
- ANGIOGRAPHIC CONTRAST MANAGEMENT SYSTEM, MODEL PART A AND PART B
- Applicant
- Invasatec
- Decision
- Substantially Equivalent
- Date received
- 1998-11-25
- Decision date
- 2000-05-31
- Days to decision
- 553 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 Medical Systems, BT2000 Automated Manifold Kit (SKU 014613) and CPT2000 (SKU 014623) recall (Z-0744-2016) | Acist Medical Systems | 2016-02-02 |
| ACIST Multi-Use Syringe Kit, Model A2000; SKU # : 014612; labeled as STERILE; Manufactured recall (Z-0359-2008) | Acist Medical Systems | 2007-12-08 |
| 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 |