510(k) K830755 ยท FPA Set, Administration, Intravascular
I.V. SETS WALRUS BRAND VARIOUS CONFIGUR-
| Applicant | Medical Parameters, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Apr 28, 1983 |
| Received | Mar 10, 1983 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K830755
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 7, 2018 | Bayer 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 |
FPA | None listed |
| Mar 30, 2010 | Arrow 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 |
FPA | None listed |
| Mar 30, 2010 | Arrow 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 |
FPA | None listed |
| Mar 30, 2010 | Arrow 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 |
FPA | None listed |
| Mar 30, 2010 | Arrow 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 |
FPA | None listed |
| Mar 30, 2010 | Arrow 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 |
FPA | None listed |
| Mar 30, 2010 | Arrow 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 |
FPA | None listed |
| Mar 30, 2010 | Arrow 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 |
FPA | None listed |
| Mar 30, 2010 | Arrow 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 |
FPA | None listed |
| Mar 30, 2010 | Arrow 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 |
FPA | None listed |
| Mar 30, 2010 | Arrow 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 |
FPA | None listed |
| Mar 30, 2010 | Arrow 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 |
FPA | None listed |
| Mar 30, 2010 | Arrow 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 |
FPA | None listed |
| Mar 30, 2010 | Arrow 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 |
FPA | None listed |
| Mar 30, 2010 | Arrow 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 |
FPA | None listed |
| Mar 30, 2010 | Arrow 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 |
FPA | None listed |
| Mar 30, 2010 | Arrow 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 |
FPA | None listed |
| Mar 30, 2010 | Arrow 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 |
FPA | None listed |
| Mar 30, 2010 | Arrow 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 |
FPA | None listed |
| Mar 30, 2010 | Arrow 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 |
FPA | None listed |
| Jun 24, 2009 | Arrow International Inc Arrow 4way Hi-Flo Stopcock with male luer lock, latex free used in various IV kits. Terminated |
FPA | None listed |
| Jun 24, 2009 | Arrow International Inc Arrow Extension sets and accessories for intravascular use. Terminated |
FPA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.