IVAC ENTERAL ADMIN. SETS, IVAC INFUSION PUMPS
FDA 510(k) clearance K946168 · decided 1996-03-21
Clearance details
- K-number
- K946168
- Device name
- IVAC ENTERAL ADMIN. SETS, IVAC INFUSION PUMPS
- Applicant
- Ivac Corporation
- Decision
- Substantially Equivalent
- Date received
- 1994-12-19
- Decision date
- 1996-03-21
- Days to decision
- 458 days
- Clearance type
- Traditional
- Product code
- LZH
- Device class
- 2
- Regulation number
- 880.5725
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- San Diego, CA, US
- Third-party review
- No
- 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 |
|---|---|---|
| TITRATOR{TM} MODEL 10K (P860035/S005) | Ivac Corporation | 1993-03-10 |
| TITRATOR{TM} MODEL 10K (P860035/S003) | Ivac Corporation | 1991-04-18 |
| TITRATOR{TM} MODEL 10K (P860035/S004) | Ivac Corporation | 1990-12-28 |
| TITRATOR{TM} MODEL 10K (P860035/S002) | Ivac Corporation | 1990-12-20 |
| TITRATOR{TM} MODEL 10K (P860035/S001) | Ivac Corporation | 1989-05-01 |
| TITRATOR MODEL 10K (P860035) | Ivac Corporation | 1987-12-17 |