Atlas FDA

LOW VOLUME MULTIPORT

FDA 510(k) clearance K943770 · decided 1995-04-10

Clearance details

K-number
K943770
Device name
LOW VOLUME MULTIPORT
Applicant
B. Braun of America, Inc.
Decision
Substantially Equivalent
Date received
1994-08-02
Decision date
1995-04-10
Days to decision
251 days
Clearance type
Traditional
Product code
FPA
Device class
2
Regulation number
880.5440
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
Bethlehem, PA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Anesthesia IV Set utilized in gravity IV administration sets and pump administration sets recall (Z-0610-2026)B Braun Medical Inc2025-11-26
Blood Administration Set utilized in gravity IV administration sets and pump administratio recall (Z-0617-2026)B Braun Medical Inc2025-11-26
Extension Set utilized in gravity IV administration sets and pump administration sets util recall (Z-0629-2026)B Braun Medical Inc2025-11-26
Extension Set utilized in gravity IV administration sets and pump administration sets util recall (Z-0636-2026)B Braun Medical Inc2025-11-26
Extension Set utilized in gravity IV administration sets and pump administration sets util recall (Z-0637-2026)B Braun Medical Inc2025-11-26
IV Administration Set utilized in gravity IV administration sets and pump administration s recall (Z-0655-2026)B Braun Medical Inc2025-11-26
IV Administration Set utilized in gravity IV administration sets and pump administration s recall (Z-0678-2026)B Braun Medical Inc2025-11-26
IV Administration Set utilized in gravity IV administration sets and pump administration s recall (Z-0686-2026)B Braun Medical Inc2025-11-26
IV Administration Set utilized in gravity IV administration sets and pump administration s recall (Z-0705-2026)B Braun Medical Inc2025-11-26
AET36 ANESTH EXT SET - Anesthesia Extension Set - Normally Closed Dual Manifold, Four-way recall (Z-3144-2024)B. Braun Medical, Inc.2024-09-13
Gravity and Infusion Pump Intravenous (IV) Sets using the Y-site Ultrasite Valve including recall (Z-0933-03)Braun,B Medical Inc2003-06-12