Atlas FDA

A6 LUER ACCESS DEVICE

FDA 510(k) clearance K083723 · decided 2009-06-05

Clearance details

K-number
K083723
Device name
A6 LUER ACCESS DEVICE
Applicant
B.Braun Medical, Inc.
Decision
Substantially Equivalent
Date received
2008-12-15
Decision date
2009-06-05
Days to decision
172 days
Clearance type
Traditional
Product code
FPA
Device class
2
Regulation number
880.5440
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
Allentown, 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-0607-2026)B Braun Medical Inc2025-11-26
Anesthesia IV Set utilized in gravity IV administration sets and pump administration sets recall (Z-0609-2026)B Braun Medical Inc2025-11-26
Anesthesia IV Set utilized in gravity IV administration sets and pump administration sets recall (Z-0610-2026)B Braun Medical Inc2025-11-26
Anesthesia IV Set utilized in gravity IV administration sets and pump administration sets recall (Z-0612-2026)B Braun Medical Inc2025-11-26
Anesthesia IV Set utilized in gravity IV administration sets and pump administration sets recall (Z-0614-2026)B Braun Medical Inc2025-11-26
B.BRAUN utilized in gravity IV administration sets and pump administration sets utilized w recall (Z-0615-2026)B Braun Medical Inc2025-11-26
Blood Administration Set utilized in gravity IV administration sets and pump administratio recall (Z-0616-2026)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
Blood Administration Set utilized in gravity IV administration sets and pump administratio recall (Z-0619-2026)B Braun Medical Inc2025-11-26
Burette Set utilized in gravity IV administration sets and pump administration sets utiliz recall (Z-0622-2026)B Braun Medical Inc2025-11-26
Caresite utilized in gravity IV administration sets and pump administration sets utilized recall (Z-0624-2026)B Braun Medical Inc2025-11-26
Caresite utilized in gravity IV administration sets and pump administration sets utilized recall (Z-0625-2026)B Braun Medical Inc2025-11-26
Caresite utilized in gravity IV administration sets and pump administration sets utilized recall (Z-0626-2026)B Braun Medical Inc2025-11-26
Extension Set utilized in gravity IV administration sets and pump administration sets util recall (Z-0627-2026)B Braun Medical Inc2025-11-26
Extension Set utilized in gravity IV administration sets and pump administration sets util recall (Z-0628-2026)B Braun Medical Inc2025-11-26
Extension Set utilized in gravity IV administration sets and pump administration sets util recall (Z-0633-2026)B Braun Medical Inc2025-11-26
IV Administration Set utilized in gravity IV administration sets and pump administration s recall (Z-0652-2026)B Braun Medical Inc2025-11-26
IV Administration Set utilized in gravity IV administration sets and pump administration s recall (Z-0653-2026)B Braun Medical Inc2025-11-26
IV Administration Set utilized in gravity IV administration sets and pump administration s recall (Z-0654-2026)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-0656-2026)B Braun Medical Inc2025-11-26
IV Administration Set utilized in gravity IV administration sets and pump administration s recall (Z-0657-2026)B Braun Medical Inc2025-11-26
IV Administration Set utilized in gravity IV administration sets and pump administration s recall (Z-0658-2026)B Braun Medical Inc2025-11-26
IV Administration Set utilized in gravity IV administration sets and pump administration s recall (Z-0659-2026)B Braun Medical Inc2025-11-26
IV Administration Set utilized in gravity IV administration sets and pump administration s recall (Z-0660-2026)B Braun Medical Inc2025-11-26
IV Administration Set utilized in gravity IV administration sets and pump administration s recall (Z-0661-2026)B Braun Medical Inc2025-11-26
IV Administration Set utilized in gravity IV administration sets and pump administration s recall (Z-0662-2026)B Braun Medical Inc2025-11-26
IV Administration Set utilized in gravity IV administration sets and pump administration s recall (Z-0663-2026)B Braun Medical Inc2025-11-26
IV Administration Set utilized in gravity IV administration sets and pump administration s recall (Z-0664-2026)B Braun Medical Inc2025-11-26
IV Administration Set utilized in gravity IV administration sets and pump administration s recall (Z-0676-2026)B Braun Medical Inc2025-11-26
IV Administration Set utilized in gravity IV administration sets and pump administration s recall (Z-0683-2026)B Braun Medical Inc2025-11-26
IV Administration Set utilized in gravity IV administration sets and pump administration s recall (Z-0684-2026)B Braun Medical Inc2025-11-26
IV Administration Set utilized in gravity IV administration sets and pump administration s recall (Z-0685-2026)B Braun Medical Inc2025-11-26
IV Administration Set utilized in gravity IV administration sets and pump administration s recall (Z-0687-2026)B Braun Medical Inc2025-11-26
IV Administration Set utilized in gravity IV administration sets and pump administration s recall (Z-0688-2026)B Braun Medical Inc2025-11-26
IV Administration Set utilized in gravity IV administration sets and pump administration s recall (Z-0689-2026)B Braun Medical Inc2025-11-26
IV Administration Set utilized in gravity IV administration sets and pump administration s recall (Z-0690-2026)B Braun Medical Inc2025-11-26
IV Administration Set utilized in gravity IV administration sets and pump administration s recall (Z-0691-2026)B Braun Medical Inc2025-11-26
IV Administration Set utilized in gravity IV administration sets and pump administration s recall (Z-0692-2026)B Braun Medical Inc2025-11-26
IV Administration Set utilized in gravity IV administration sets and pump administration s recall (Z-0693-2026)B Braun Medical Inc2025-11-26
IV Administration Set utilized in gravity IV administration sets and pump administration s recall (Z-0694-2026)B Braun Medical Inc2025-11-26
IV Administration Set utilized in gravity IV administration sets and pump administration s recall (Z-0695-2026)B Braun Medical Inc2025-11-26
IV Administration Set utilized in gravity IV administration sets and pump administration s recall (Z-0696-2026)B Braun Medical Inc2025-11-26
IV Administration Set utilized in gravity IV administration sets and pump administration s recall (Z-0698-2026)B Braun Medical Inc2025-11-26
IV Administration Set utilized in gravity IV administration sets and pump administration s recall (Z-0699-2026)B Braun Medical Inc2025-11-26
IV Administration Set utilized in gravity IV administration sets and pump administration s recall (Z-0703-2026)B Braun Medical Inc2025-11-26
IV Administration Set utilized in gravity IV administration sets and pump administration s recall (Z-0704-2026)B Braun Medical Inc2025-11-26
Outlook set utilized in gravity IV administration sets and pump administration sets utiliz recall (Z-0706-2026)B Braun Medical Inc2025-11-26
Outlook set utilized in gravity IV administration sets and pump administration sets utiliz recall (Z-0707-2026)B Braun Medical Inc2025-11-26
Outlook set utilized in gravity IV administration sets and pump administration sets utiliz recall (Z-0709-2026)B Braun Medical Inc2025-11-26