E-Z-EM PULSED INFUSION SYSTEM
FDA 510(k) clearance K905447 · decided 1991-04-01
Clearance details
- K-number
- K905447
- Device name
- E-Z-EM PULSED INFUSION SYSTEM
- Applicant
- E-Z-Em, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1990-12-05
- Decision date
- 1991-04-01
- Days to decision
- 117 days
- Clearance type
- Traditional
- Product code
- KRA
- Device class
- 2
- Regulation number
- 870.1210
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Worcester, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Uni*Fuse INFUSION SYSTEM WITH COOPER WIRE, 5F x 90 cm x 10 cm Infusion Pattern, Catalog No recall (Z-2260-2014) | Angiodynamics, Inc. | 2014-08-18 |
| Uni*Fuse INFUSION SYSTEM WITH COOPER WIRE, 5F x 90 cm x 30 cm Infusion Pattern, Catalog No recall (Z-2261-2014) | Angiodynamics, Inc. | 2014-08-18 |
| Uni*Fuse INFUSION SYSTEM WITH COOPER WIRE, 5F x 90 cm x 40 cm Infusion Pattern, Catalog No recall (Z-2262-2014) | Angiodynamics, Inc. | 2014-08-18 |
| PULSESPRAY INFUSION SYSTEM, 90 cm x 20 cm infusion length, Catalog No./Ref 12500402, STERI recall (Z-1707-2010) | Angiodynamics, Inc. | 2010-05-27 |