AFF (MARK I) VOLUMETRIC INFUSION PUMP
FDA 510(k) clearance K070529 · decided 2007-05-08
Clearance details
- K-number
- K070529
- Device name
- AFF (MARK I) VOLUMETRIC INFUSION PUMP
- Applicant
- Definitive Medical Technologies, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2007-02-23
- Decision date
- 2007-05-08
- Days to decision
- 74 days
- Clearance type
- Traditional
- Product code
- FRN
- Device class
- 2
- Regulation number
- 880.5725
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Lod, IL
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| The pump (with cushioning foam inserts) is packaged in a single pump box. Four pump boxes recall (Z-2219-2016) | WalkMed Infusion, LLC | 2016-07-18 |
| The pump (with cushioning foam inserts) is packaged in a single pump box. Four pump boxes recall (Z-2220-2016) | WalkMed Infusion, LLC | 2016-07-18 |
| Triton Infusion Pump (model 300000) and Triton fp Infusion Pump (model 400000) (proprietar recall (Z-0242-2016) | WalkMed Infusion, LLC | 2015-11-06 |
| Triton FP Infusion Pump, Part Number 400000, packaged in boxes. The Triton Volumetric Infu recall (Z-1122-2014) | WalkMed Infusion, LLC | 2014-03-03 |
| WalkMed Triton Pole Mount Infusion Pump, Catalog 300000. Indicated for delivering infusion recall (Z-0307-2011) | Walkmed Infusion LLC | 2010-11-05 |