ClearanceBrief
510(k) K830755 ยท FPA Set, Administration, Intravascular

I.V. SETS WALRUS BRAND VARIOUS CONFIGUR-

ApplicantMedical Parameters, Inc., Mchenry IL, US
DecisionSubstantially Equivalent, Apr 28, 1983
ReceivedMar 10, 1983
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K830755

DateFirm and productCodeLinked 510(k)
Sep 7, 2018Bayer Medical Care, Inc.
Codan Filter (Codan catalog number BC 693) used with Medrad Patient Administration Sets (PAS) and Intego PET Infusion Systems Product Usage: 1.2 micron filter for use with Intravenous Administration
Terminated
FPANone listed
Mar 30, 2010Arrow International Inc
IV Sets and Accessories, various configurations. An Intravenous Administration Tubing set is a device intended for medical purposes that consists of tubing and components with suitable adaptors used
Terminated
FPANone listed
Mar 30, 2010Arrow International Inc
Y-Type Blood Pump Sets, with Detachable Polysulfone Stopcock. For Veterinary Use Only and with Two Luer Activated Y-Injection Sites, Y-Injection Site and 2 Gang 4-Way Polysulfone Stopcocks. An Intrav
Terminated
FPANone listed
Mar 30, 2010Arrow International Inc
IV Extension Set with Spike and 2-Way Stopcock. An Intravenous Administration Tubing set is a device intended for medical purposes that consists of tubing and components with suitable adaptors used t
Terminated
FPANone listed
Mar 30, 2010Arrow International Inc
15 Drop IV Sets, with Retractable Luer-Lock and with Smartsite(TM) Y-Injection sites and 4-Way Stopcock with Pressure Activated Valve Manifold. (Approx. 15 drops/ml). An Intravenous Administration Tu
Terminated
FPANone listed
Mar 30, 2010Arrow International Inc
Non-Vented IV Set with 2-Gang "Hi-Flo" Stopcocks with Luer Activated HEP Lock Valves and Luer Activated Y-Injection Sites. (Approx. 10 Drop/ML). An Intravenous Administration Tubing set is a device i
Terminated
FPANone listed
Mar 30, 2010Arrow International Inc
Positive Pressure Blood Pump Sets, with Stopcock and Smartsite(TM) Y-Injection Site and with 3-Gang 4-Way Stopcocks, Y-Injection Site and T-Connector. An Intravenous Administration Tubing set is a d
Terminated
FPANone listed
Mar 30, 2010Arrow International Inc
60 Drop IV Set with SmartSite(TM) Y-Injection Sites, 2-Gang Standard Bore Stopcocks and T-Connector. (Approx. 60 Drops/ML) SmartSite(TM) is a trademark of Alaris Medical Systems, Inc. An Intravenous
Terminated
FPANone listed
Mar 30, 2010Arrow International Inc
150ML Burette IV Set with SmartSite(TM) Y-Injection Site, 2-Gang Standard Bore Stopcocks and T-Connector SmartSite(TM) is a trademark of Alaris Medical Systems, Inc. An Intravenous Administration Tub
Terminated
FPANone listed
Mar 30, 2010Arrow International Inc
20 Drop IV Set with 3 SmartSite(TM) Y-Injection Sites, 2-Gang 4-Way Stopcock and Novex Stopcock. (Approx. 20 Drops/ML) SmartSite(TM) is a trademark of Alaris Medical Systems, Inc. An Intravenous Admi
Terminated
FPANone listed
Mar 30, 2010Arrow International Inc
8" Microbore Extension with Detachable SmartSite(TM) HEP-Lock and Retractable Spinning Luerlock. DEHP-Free SmartSite(TM) is a trademark of Alaris Medical Systems, Inc. An Intravenous Administration T
Terminated
FPANone listed
Mar 30, 2010Arrow International Inc
IV Set with Two SmartSite(TM) Y-Injection Sites, Stopcock and 3-Gang Pressure Activated Manifold Valve and Rotating Luer Lock End SmartSite(TM) is a trademark of Alaris Medical Systems, Inc. An Intra
Terminated
FPANone listed
Mar 30, 2010Arrow International Inc
8" Extension Set with SmartSite(TM) HEP-Lock and Rotating Luer Lock. SmartSite(TM) is a trademark of Alaris Medical Systems, Inc. An Intravenous Administration Tubing set is a device intended for med
Terminated
FPANone listed
Mar 30, 2010Arrow International Inc
10 Drop IV Sets, with 3 Pre-Pierced Y-Injection Sites and 3-Gang Pressure Activated Manifold Valve. (Approx. 10 Drops/ML); with Two Y-Injection Sites and Rotating Luer Lock (Approx. 10 Drop/ML); with
Terminated
FPANone listed
Mar 30, 2010Arrow International Inc
Y-Type Positive Pressure Pump Set with 2-Gang 4-Way Stopcock and Detachable 4-Way Stopcock. An Intravenous Administration Tubing set is a device intended for medical purposes that consists of tubing
Terminated
FPANone listed
Mar 30, 2010Arrow International Inc
7" Non-Kink Extension Set with Rotating Luer-Lock Connector. An Intravenous Administration Tubing set is a device intended for medical purposes that consists of tubing and components with suitable ad
Terminated
FPANone listed
Mar 30, 2010Arrow International Inc
Positive Pressure Blood Pumps, with Pre-Pierced Y-Injection Site; with Three SmartSite(TM)Injection Sites and Rotating Male Luer Lock. SmartSite(TM) is a trademark of Alaris Medical Systems, Inc; with
Terminated
FPANone listed
Mar 30, 2010Arrow International Inc
Y Type Blood Pump Sets, with 2 Vented Spikes and Double "Hi-Flo" Stopcock; with Luer Activated Y-Injection Sites, Y-Injection Site and 2 Gang 4-Way Stopcocks; with "Hi-Flo" Stopcocks and SmartSite(TM)
Terminated
FPANone listed
Mar 30, 2010Arrow International Inc
4-Way "Hi-Flo" Extension Set with Two SmartSite(TM) Y-Injection Sites and Rotating Luer Lock SmartSite(TM) is a trademark of Alaris Medical Systems, Inc. An Intravenous Administration Tubing set is a
Terminated
FPANone listed
Mar 30, 2010Arrow International Inc
Burette Set with SmartSite(TM) Y-Injection Site and SmartSite(TM) HEP-Lock on Burette SmartSite(TM) is a trademark of Alaris Medical Systems, Inc. An Intravenous Administration Tubing set is a device
Terminated
FPANone listed
Jun 24, 2009Arrow International Inc
Arrow 4way Hi-Flo Stopcock with male luer lock, latex free used in various IV kits.
Terminated
FPANone listed
Jun 24, 2009Arrow International Inc
Arrow Extension sets and accessories for intravascular use.
Terminated
FPANone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.