Atlas FDA

I.V. SETS WALRUS BRAND VARIOUS CONFIGUR-

FDA 510(k) clearance K830755 · decided 1983-04-28

Clearance details

K-number
K830755
Device name
I.V. SETS WALRUS BRAND VARIOUS CONFIGUR-
Applicant
Medical Parameters, Inc.
Decision
Substantially Equivalent
Date received
1983-03-10
Decision date
1983-04-28
Days to decision
49 days
Clearance type
Traditional
Product code
FPA
Device class
2
Regulation number
880.5440
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
Mchenry, IL, US
Third-party review
No
Expedited review
No

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RecordFirmDate
iiSure Infusion Set (K261530)Deka Research and Development2026-06-03
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nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731]; nSyte Needle Free Connector (NFC) [6426727] (K251257)Np Medical2025-12-04
BD Alaris Pump Infusion Set (K250325)Carefusion (Bd)2025-10-30
EZ™ IV Administration Set (K251814)Epic Medical Pte. , Ltd.2025-08-29
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Sparta Infusion Set for Insulin (K243841)Deka Research and Development2025-08-01
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Recalls involving this device

RecordFirmDate
IV Sets and Accessories, various configurations. An Intravenous Administration Tubing set recall (Z-1112-2010)Arrow International Inc2010-03-30
Y-Type Blood Pump Sets, with Detachable Polysulfone Stopcock. For Veterinary Use Only and recall (Z-1113-2010)Arrow International Inc2010-03-30
IV Extension Set with Spike and 2-Way Stopcock. An Intravenous Administration Tubing set i recall (Z-1114-2010)Arrow International Inc2010-03-30
15 Drop IV Sets, with Retractable Luer-Lock and with Smartsite(TM) Y-Injection sites and 4 recall (Z-1115-2010)Arrow International Inc2010-03-30
Non-Vented IV Set with 2-Gang "Hi-Flo" Stopcocks with Luer Activated HEP Lock Valves and L recall (Z-1116-2010)Arrow International Inc2010-03-30
Positive Pressure Blood Pump Sets, with Stopcock and Smartsite(TM) Y-Injection Site and wi recall (Z-1117-2010)Arrow International Inc2010-03-30
60 Drop IV Set with SmartSite(TM) Y-Injection Sites, 2-Gang Standard Bore Stopcocks and T- recall (Z-1118-2010)Arrow International Inc2010-03-30
150ML Burette IV Set with SmartSite(TM) Y-Injection Site, 2-Gang Standard Bore Stopcocks a recall (Z-1119-2010)Arrow International Inc2010-03-30
20 Drop IV Set with 3 SmartSite(TM) Y-Injection Sites, 2-Gang 4-Way Stopcock and Novex Sto recall (Z-1120-2010)Arrow International Inc2010-03-30
8" Microbore Extension with Detachable SmartSite(TM) HEP-Lock and Retractable Spinning Lue recall (Z-1121-2010)Arrow International Inc2010-03-30
IV Set with Two SmartSite(TM) Y-Injection Sites, Stopcock and 3-Gang Pressure Activated Ma recall (Z-1122-2010)Arrow International Inc2010-03-30
8" Extension Set with SmartSite(TM) HEP-Lock and Rotating Luer Lock. SmartSite(TM) is a tr recall (Z-1123-2010)Arrow International Inc2010-03-30
10 Drop IV Sets, with 3 Pre-Pierced Y-Injection Sites and 3-Gang Pressure Activated Manifo recall (Z-1124-2010)Arrow International Inc2010-03-30
Y-Type Positive Pressure Pump Set with 2-Gang 4-Way Stopcock and Detachable 4-Way Stopcock recall (Z-1125-2010)Arrow International Inc2010-03-30
7" Non-Kink Extension Set with Rotating Luer-Lock Connector. An Intravenous Administration recall (Z-1126-2010)Arrow International Inc2010-03-30
Positive Pressure Blood Pumps, with Pre-Pierced Y-Injection Site; with Three SmartSite(TM) recall (Z-1127-2010)Arrow International Inc2010-03-30
Y Type Blood Pump Sets, with 2 Vented Spikes and Double "Hi-Flo" Stopcock; with Luer Activ recall (Z-1128-2010)Arrow International Inc2010-03-30
4-Way "Hi-Flo" Extension Set with Two SmartSite(TM) Y-Injection Sites and Rotating Luer Lo recall (Z-1129-2010)Arrow International Inc2010-03-30
Burette Set with SmartSite(TM) Y-Injection Site and SmartSite(TM) HEP-Lock on Burette Smar recall (Z-1130-2010)Arrow International Inc2010-03-30
Arrow 4way Hi-Flo Stopcock with male luer lock, latex free used in various IV kits. recall (Z-1489-2009)Arrow International Inc2009-06-24
Arrow Extension sets and accessories for intravascular use. recall (Z-1490-2009)Arrow International Inc2009-06-24