Precision Delivery Infusion Set
FDA 510(k) clearance K202672 · decided 2021-01-21
Clearance details
- K-number
- K202672
- Device name
- Precision Delivery Infusion Set
- Applicant
- Quest Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2020-09-15
- Decision date
- 2021-01-21
- Days to decision
- 128 days
- Clearance type
- Traditional
- Product code
- FPA
- Device class
- 2
- Regulation number
- 880.5440
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Allen, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Precision Delivery Set with Filter, REF: PD06F; and Precision Delivery Set with Trifurcate recall (Z-1100-2023) | Quest Medical, Inc. | 2023-02-07 |