LIFESHIELD PRIMARY I.V. SET WITH BACKCHECK VALVE
FDA 510(k) clearance K971293 · decided 1997-06-27
Clearance details
- K-number
- K971293
- Device name
- LIFESHIELD PRIMARY I.V. SET WITH BACKCHECK VALVE
- Applicant
- Abbott Mfg., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-04-07
- Decision date
- 1997-06-27
- Days to decision
- 81 days
- Clearance type
- Traditional
- Product code
- FPA
- Device class
- 2
- Regulation number
- 880.5440
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Abbott Park, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Primary I.V. Gravity Administration Sets; sterile, Rx, single use devices; Abbott Laborato recall (Z-0957-03) | Abbott Laboratories HPD/ADD | 2003-06-27 |