EZ SET INFUSION SET
FDA 510(k) clearance K012754 · decided 2001-08-27
Clearance details
- K-number
- K012754
- Device name
- EZ SET INFUSION SET
- Applicant
- Animas Corp.
- Decision
- Substantially Equivalent
- Date received
- 2001-08-16
- Decision date
- 2001-08-27
- Days to decision
- 11 days
- Clearance type
- Traditional
- Product code
- FPA
- Device class
- 2
- Regulation number
- 880.5440
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Frazer, PA, US
- Third-party review
- Yes
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Animas Vibe System (P130007/S036) | Animas Corp. | 2018-07-11 |
| Animas Vibe System (P130007/S035) | Animas Corp. | 2018-04-18 |
| Animas Vibe System (P130007/S034) | Animas Corp. | 2018-03-12 |
| Animas Vibe System (P130007/S033) | Animas Corp. | 2018-03-01 |
| Animas Vibe System (P130007/S027) | Animas Corp. | 2017-10-27 |
| Animas Vibe System (P130007/S031) | Animas Corp. | 2017-10-24 |
| Animas Vibe System (P130007/S029) | Animas Corp. | 2017-08-17 |
| Animas, Vibe System (P130007/S026) | Animas Corp. | 2017-06-09 |