Atlas FDA

CLOSED SWABABLE STOPCOCK AND MINIMAL RESIDUAL VOLUME LUER-ACTIVATED SWABABLE-STOPCOCK

FDA 510(k) clearance K060231 · decided 2006-04-13

Clearance details

K-number
K060231
Device name
CLOSED SWABABLE STOPCOCK AND MINIMAL RESIDUAL VOLUME LUER-ACTIVATED SWABABLE-STOPCOCK
Applicant
Elcam Medical Acal
Decision
Substantially Equivalent
Date received
2006-01-30
Decision date
2006-04-13
Days to decision
73 days
Clearance type
Special
Product code
FMG
Device class
2
Regulation number
880.5440
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
Mp. Merom Hagalil, IL
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-0606-2026)B Braun Medical Inc2025-11-26
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-0608-2026)B Braun Medical Inc2025-11-26
IV Administration Set utilized in gravity IV administration sets and pump administration s recall (Z-0645-2026)B Braun Medical Inc2025-11-26
IV Administration Set utilized in gravity IV administration sets and pump administration s recall (Z-0646-2026)B Braun Medical Inc2025-11-26
IV Administration Set utilized in gravity IV administration sets and pump administration s recall (Z-0647-2026)B Braun Medical Inc2025-11-26
IV Administration Set utilized in gravity IV administration sets and pump administration s recall (Z-0648-2026)B Braun Medical Inc2025-11-26
IV Administration Set utilized in gravity IV administration sets and pump administration s recall (Z-0649-2026)B Braun Medical Inc2025-11-26
IV Administration Set utilized in gravity IV administration sets and pump administration s recall (Z-0650-2026)B Braun Medical Inc2025-11-26
IV Administration Set utilized in gravity IV administration sets and pump administration s recall (Z-0651-2026)B Braun Medical Inc2025-11-26
Outlook set utilized in gravity IV administration sets and pump administration sets utiliz recall (Z-0708-2026)B Braun Medical Inc2025-11-26
SAFSITE Injection Sites and IV Sets manufactured with SAFSITE Injection Sites. A device us recall (Z-0987-2014)B. Braun Medical, Inc.2014-02-18
Anesthesia IV Set with Universal Spike, Backcheck Valve, two Ultrasite Injection Sites, In recall (Z-1432-2009)B. Braun Medical, Inc.2009-06-05
Hospira Intralock Lipid Compatible 3-Way Stopcock, Item Number 423830401 Indicated for flu recall (Z-2205-2008)ICU Medical, Inc.2008-09-16
Hospira Monitoring Kit (PA Line) with 03ml Flush Device for Saginaw General Hosp. , Item N recall (Z-2206-2008)ICU Medical, Inc.2008-09-16
Hospira Left Heart Kit for Southwestern M.C. , Item Number: 46084053 Indicated for fluid f recall (Z-2207-2008)ICU Medical, Inc.2008-09-16
ICU Medical, Inc. Cath Lab Kit W/3Port "ON" Manifold, Waste Bag, Syringe & TP4; Item Numbe recall (Z-2208-2008)ICU Medical, Inc.2008-09-16