ADDEASE 20MM BINARY CONNECTOR WITH 17 GA. NEEDLE— 510(k) K090905
Substantially EquivalentB.Braun Medical, Inc.
FDA 510(k) clearance K090905 for ADDEASE 20MM BINARY CONNECTOR WITH 17 GA. NEEDLE, Substantially Equivalent on 2009-04-27. Applicant: B.Braun Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- B.Braun Medical, 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
- Special
- Location
- Allentown, PA, US
Recent devices under product code LHI
view allMore clearances from B.Braun Medical, 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 K090905
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 K090905.
Data sourced from openFDA. This site is unofficial and independent of the FDA.