DISPENSING PIN WITH ONE-WAY VALVE— 510(k) K943181
Substantially EquivalentB. Braun of America, Inc.
FDA 510(k) clearance K943181 for DISPENSING PIN WITH ONE-WAY VALVE, Substantially Equivalent on 1994-09-29. Applicant: B. Braun of America, Inc.. Device class: 2.
Clearance details
- Applicant
- B. Braun of America, 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
- Bethlehem, PA, US
Recent devices under product code LHI
view allMore clearances from B. Braun of America, 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 K943181
K-number listed on FDA's recall record- Z-1906-2016 — Non-Vented Dispensing Pin with One-Way Valve and Luer Lock Ultrasite Valve Product Usage: Used for aspiration of medication from inverted bags or semi-rigid containers. Interavenous delivery of transferred medication(Device is not intended for direct infusion)
- Z-1907-2016 — Non-Vented Dispensing Pin with Luer Lock Ultrasite Valve Product Usage: Used for aspiration of medication from inverted bags or semi-rigid containers. Interavenous delivery of transferred medication(Device is not intended for direct infusion)
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K943181.
Data sourced from openFDA. This site is unofficial and independent of the FDA.