VENTED/NON-VENTED GEMINI ADMINISTRATION SET
FDA 510(k) clearance K944320 · decided 1995-02-14
Clearance details
- K-number
- K944320
- Device name
- VENTED/NON-VENTED GEMINI ADMINISTRATION SET
- Applicant
- Imed Corp.
- Decision
- Substantially Equivalent
- Date received
- 1994-08-29
- Decision date
- 1995-02-14
- Days to decision
- 169 days
- Clearance type
- Traditional
- Product code
- FPA
- Device class
- 2
- Regulation number
- 880.5440
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Alaris Pump SmartSite Infusion Set, Model No. 2420-0500. Used to administer fluid and medi recall (Z-0445-2016) | CareFusion 303, Inc. | 2015-12-17 |
| SmartSite Low Sorbing Infusion Set, Model Codes: 10014855A, 10015861A, 10061661A 14035457 recall (Z-2025-2014) | CareFusion 303, Inc. | 2014-07-09 |
| SmartSite Low Sorbing Infusion Set with Texium Close Male Luer, Model No. 24301-0007T The recall (Z-0450-2014) | CareFusion 303, Inc. | 2013-12-04 |
| VersaSafe Extension Set, Model No. 21000M-007 recall (Z-0435-2014) | CareFusion 303, Inc. | 2013-12-03 |
| SmartSite Low Sorbing Infusion Set, Model# 10015048. Intravascular administration set. recall (Z-2285-2013) | CareFusion 303, Inc. | 2013-09-26 |