Atlas FDA

V2 INJECTION SITE

FDA 510(k) clearance K955585 · decided 1996-05-15

Clearance details

K-number
K955585
Device name
V2 INJECTION SITE
Applicant
B.Braun Medical, Inc.
Decision
Substantially Equivalent
Date received
1995-12-07
Decision date
1996-05-15
Days to decision
160 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
ULTRASITE set utilized in gravity IV administration sets and pump administration sets util recall (Z-0714-2026)B Braun Medical Inc2025-11-26
ULTRASITE US04TL Smallbore T-Port Extension Set, Product Code 474515, 100 units per carton recall (Z-0090-2023)B. Braun Medical, Inc.2022-10-14
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
Outlook Safety Infusion System Burette Set. For intravenous fluid administration. recall (Z-2166-2013)B. Braun Medical, Inc.2013-09-06
Outlook Pump IV Set w/Universal Spike, 3 Ultrasite Inj Sites B/C Valve & Pressure Limited recall (Z-0678-2010)B. Braun Medical, Inc.2010-01-26
Outlook Pump Set w/150 ml Burette w/15um Filter & Ultrasite Inj Site, B/C Valve, 2 Ultrasi recall (Z-0684-2010)B. Braun Medical, Inc.2010-01-26
Outlook Pump Set w/Universal Spike, 3 Ultrasite Inj Sites, Spin Lock Con & Pressure, Limit recall (Z-0685-2010)B. Braun Medical, Inc.2010-01-26
Outlook Pump IV Set w/Universal Spike, Ultrasite Inj Site, B/C Valve and Pressure Limited recall (Z-0686-2010)B. Braun Medical, Inc.2010-01-26
Outlook Pump IV Set w/Universal Spike, Pressure Limited Check Valve, 3 Safsite Inj Sites, recall (Z-0706-2010)B. Braun Medical, Inc.2010-01-26
Safesite Y Type Blood Set for Outlook Pump w/Safesite Inj Site 170um Blood Filter, Spin Lo recall (Z-0707-2010)B. Braun Medical, Inc.2010-01-26
Outlook Pump IV Set w/Universal Spike, Pressure Limited Check Valve, 3 Ultrasite Injection recall (Z-0708-2010)B. Braun Medical, Inc.2010-01-26
IV Administration Set with Universal Spike, two Ultrasite Injection Sites, Backcheck Valve recall (Z-1427-2009)B. Braun Medical, Inc.2009-06-05
Ultrasite IV Set for Outlook Safety Infusion System with Universal Spike, Pressure Limited recall (Z-1428-2009)B. Braun Medical, Inc.2009-06-05
Primary IV Set with Universal Spike, Backcheck Valve, 3 Ultrasite Injection Sites and Spin recall (Z-1429-2009)B. Braun Medical, Inc.2009-06-05
Ultrasite IV Administration Set with Universal Spike, three Backcheck Valves, three Ultras recall (Z-1430-2009)B. Braun Medical, Inc.2009-06-05
Outlook Safety Infusion System IV Set with Universal Spike, Backcheck Valve, Ultrasite Inj recall (Z-1431-2009)B. Braun Medical, Inc.2009-06-05
Anesthesia IV Set with Universal Spike, Backcheck Valve, two Ultrasite Injection Sites, In recall (Z-1432-2009)B. Braun Medical, Inc.2009-06-05
Ultrasite ADDitIV Primary IV Set with Universal Spike, Backcheck Valve, two Ultrasite Inje recall (Z-1433-2009)B. Braun Medical, Inc.2009-06-05
Smallbore T-Port Extension Set with Female Luer Lock Connector and Male Luer Lock T-Port w recall (Z-0199-2009)B. Braun Medical, Inc.2008-10-24
Horizon Pump Set w/150 ml burette w/15 um filter and Ultrasite inj site, 2 Ultrasite inj s recall (Z-2407-2008)B. Braun Medical, Inc.2008-09-23
Metriset Burette Set w/Horizon Pump, Ultrasites, 120 in. Item/Catalog number 375150. The p recall (Z-2410-2008)B. Braun Medical, Inc.2008-09-23
Burette Set w/150 ml Burette w/15 um filter & Ultrasite inj site, Ultrasite inj site, 88 i recall (Z-2411-2008)B. Braun Medical, Inc.2008-09-23
Add-On Burette Set with 150 ml burette and Ultrasite Injection Site without automatic shut recall (Z-2412-2008)B. Braun Medical, Inc.2008-09-23
Add-On Burette Set with 150 ml burette 7 Ultrasite Injection Site with automatic shutoff, recall (Z-2413-2008)B. Braun Medical, Inc.2008-09-23
Ultrasite Horizon Pump IV Set. The product is shipped in cases containing 24 sets. recall (Z-0818-2007)B. Braun Medical, Inc.2007-05-31
Horizon Pump Metriset Burette Set. The product is shipped in cases containing 20 sets. recall (Z-0819-2007)B. Braun Medical, Inc.2007-05-31
Gravity and Infusion Pump Intravenous (IV) Sets using the Y-site Ultrasite Valve including recall (Z-0933-03)Braun,B Medical Inc2003-06-12