PLUM A+ INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE , AND PLUM A+3 INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE
FDA 510(k) clearance K042081 · decided 2004-08-24
Clearance details
- K-number
- K042081
- Device name
- PLUM A+ INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE , AND PLUM A+3 INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE
- Applicant
- Hospira, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-08-03
- Decision date
- 2004-08-24
- Days to decision
- 21 days
- Clearance type
- Traditional
- Product code
- FRN
- Device class
- 2
- Regulation number
- 880.5725
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Lake Forest, IL, US
- Third-party review
- Yes
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Hospira
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| DEXTRAN HM 32% HYSTEROSCOPIC DISTENTION MEDIUM (P880028/S008) | Hospira, Inc. | 1999-01-29 |
| DEXTRAN HM 32% HYSTEROSCOPIC DISTENTION MEDIUM (P880028/S007) | Hospira, Inc. | 1996-09-05 |
| DEXTRAN HM 32% HYSTEROSCOPIC DISTENTION MEDIUM (P880028/S006) | Hospira, Inc. | 1996-01-04 |
| DEXTRAN HM 32% HYSTEROSCOPIC DISTENTION MEDIUM (P880028/S003) | Hospira, Inc. | 1995-12-15 |
| DEXTRAN HM 32 (P880028/S002) | Hospira, Inc. | 1990-11-15 |
| DEXTRAN HM 32 (P880028/S001) | Hospira, Inc. | 1989-12-29 |
| DEXTRAN HM 32% (P880028) | Hospira, Inc. | 1989-05-30 |