ADDEASE 20MM BINARY CONNECTOR WITH 17 GA. NEEDLE
FDA 510(k) clearance K090905 · decided 2009-04-27
Clearance details
- K-number
- K090905
- Device name
- ADDEASE 20MM BINARY CONNECTOR WITH 17 GA. NEEDLE
- Applicant
- B.Braun Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2009-04-01
- Decision date
- 2009-04-27
- Days to decision
- 26 days
- Clearance type
- Special
- Product code
- LHI
- Device class
- 2
- Regulation number
- 880.5440
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Allentown, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| 20mm addEASE(TM) Binary Connector with 17 Ga. Needle for use with PAB(R) Containers, BC200 recall (Z-0424-2014) | B. Braun Medical, Inc. | 2013-11-27 |
| 13mm addEASE(TM) Binary Connector with 17 Ga. Needle for use with PAB(R) Containers, BC130 recall (Z-0425-2014) | B. Braun Medical, Inc. | 2013-11-27 |
| B. Braun addEASE Binary Connector, Catalogue #N7990, 200 units (50 units per bag with 4 ba recall (Z-0305-2011) | B. Braun Medical Inc | 2010-11-05 |
| B. Braun addEASE Binary Connector, Catalogue #N7993, 200 units (50 units per bag with 4 ba recall (Z-0306-2011) | B. Braun Medical Inc | 2010-11-05 |