ADD-A-VIAL II BINARY CONNECTOR
FDA 510(k) clearance K900865 · decided 1990-07-11
Clearance details
- K-number
- K900865
- Device name
- ADD-A-VIAL II BINARY CONNECTOR
- Applicant
- Kendall Mcgaw Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1990-02-23
- Decision date
- 1990-07-11
- Days to decision
- 138 days
- Clearance type
- Traditional
- Product code
- LHI
- Device class
- 2
- Regulation number
- 880.5440
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Santa Ana, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Kendall Mcgaw Laboratories
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
| 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 |