INVISION-PLUS INJECTION PORT CONNECTOR SYSTEM
FDA 510(k) clearance K991653 · decided 1999-06-24
Clearance details
- K-number
- K991653
- Device name
- INVISION-PLUS INJECTION PORT CONNECTOR SYSTEM
- Applicant
- Rymed Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-05-13
- Decision date
- 1999-06-24
- Days to decision
- 42 days
- Clearance type
- Traditional
- Product code
- FPA
- Device class
- 2
- Regulation number
- 880.5440
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Miami, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| InVision-Plus and InVision-Plus Junior Needleless IV Connector, Disposable, Single Use Pro recall (Z-0675-2016) | Rymed Technologies, LLC | 2016-01-21 |
| RYM-5000 InVision-Plus Neutral Displacement I.V. Connector, packaged 200 units per box, 5 recall (Z-0319-2007) | Rymed Technologies, Inc. | 2006-12-30 |
| RYM-5000 InVision-Plus NEUTRAL I.V. Connector, packaged 200 units per box, 5 boxes per cas recall (Z-0320-2007) | Rymed Technologies, Inc. | 2006-12-30 |
| RYM-5001 InVision-Plus Neutral Displacement I.V. Connector, packaged 100 units per box, 5 recall (Z-0321-2007) | Rymed Technologies, Inc. | 2006-12-30 |