ADD-A-VIAL II BINARY CONNECTOR— 510(k) K900865
Substantially EquivalentKendall Mcgaw Laboratories, Inc.
FDA 510(k) clearance K900865 for ADD-A-VIAL II BINARY CONNECTOR, Substantially Equivalent on 1990-07-11. Applicant: Kendall Mcgaw Laboratories, Inc.. Device class: 2.
Clearance details
- Applicant
- Kendall Mcgaw Laboratories, Inc.
- Product code
- Code LHI
- Device class
- Class 2
- Regulation
- 21 CFR 880.5440
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Santa Ana, CA, US
Recent devices under product code LHI
view allMore clearances from Kendall Mcgaw Laboratories, Inc.
view allAdverse events under product code LHI
product code LHI- Injury
- 207
- Malfunction
- 7,820
- Other
- 3
- Total
- 8,030
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K900865
K-number listed on FDA's recall record- Z-0424-2014 — 20mm addEASE(TM) Binary Connector with 17 Ga. Needle for use with PAB(R) Containers, BC2000 Product is intended for fluid transfer between a Partial Additive Bag (PAB(R)) container and a drug vial.
- Z-0425-2014 — 13mm addEASE(TM) Binary Connector with 17 Ga. Needle for use with PAB(R) Containers, BC1300 Product is intended for fluid transfer between a Partial Additive Bag (PAB(R)) container and a drug vial.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K900865.
Data sourced from openFDA. This site is unofficial and independent of the FDA.