Atlas FDA

INTRAVASCULAR ADMINISTRATION SET

FDA 510(k) clearance K891919 · decided 1989-05-05

Clearance details

K-number
K891919
Device name
INTRAVASCULAR ADMINISTRATION SET
Applicant
Multi-Med, Inc.
Decision
Substantially Equivalent
Date received
1989-03-27
Decision date
1989-05-05
Days to decision
39 days
Clearance type
Traditional
Product code
FMI
Device class
2
Regulation number
880.5570
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
West Swanzey, NH, US
Third-party review
No
Expedited review
No

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Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R, NR-S2016R, NR-S2025R, NR-S2038R, NR-S2051R, NR-S2116R, NR-S2125R, NR-S2138R, NR-S2151R, NR-S2216R, NR-S2225R, NR-S2238R, NR-S2251R, NR-S2316R, NR-S2325R, NR-S2338R, NR-S2351R, NR-S2516R, NR-S2525R, NR-S2538R, NR-S2551R, NR-S2516T, NR-S2525T, NR-S2538T, NR-S2551T) (K260933)Hangzhou Qiantang Longyue Biotechnology Co., Ltd.2026-08-07
Profoject™ Dual-Safety Pen Needles (K261829)CMT Health PTE., Ltd.2026-07-29
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Recalls involving this device

RecordFirmDate
All Med Medical 19ga x .50" Winged Administration Set w/Y Site Model # M195Y Reorder # 50- recall (Z-2506-2010)Multi-Med, Inc.2010-09-29
All Med Medical 19ga x .75" Winged Administration Set Model # M1975 Reorder # 50-1921 recall (Z-2507-2010)Multi-Med, Inc.2010-09-29
All Med Medical 19ga x .75" Winged Administration Set w/Y Site Model # M1975Y Reorder # 50 recall (Z-2508-2010)Multi-Med, Inc.2010-09-29
All Med Medical 19ga x .75" Standard Bore Winged Administration Set Model # M1975S Reorder recall (Z-2509-2010)Multi-Med, Inc.2010-09-29
All Med Medical 19ga x 1" Winged Administration Set Model # M191 Reorder # 50-1931 recall (Z-2510-2010)Multi-Med, Inc.2010-09-29
All Med Medical 19ga x 1" Winged Administration Set w/Y Site Model # M191Y Reorder # 50-19 recall (Z-2511-2010)Multi-Med, Inc.2010-09-29
All Med Medical 19ga x 1.50" Winged Administration Set w/Y Site Model # M1915Y Reorder # 5 recall (Z-2512-2010)Multi-Med, Inc.2010-09-29
All Med Medical 20ga x .50" Winged Administration Set Model # M205 Reorder # 50-2011 recall (Z-2513-2010)Multi-Med, Inc.2010-09-29
All Med Medical 20ga x .50" Winged Administration Set w/Y Site Model # M205Y Reorder # 50- recall (Z-2514-2010)Multi-Med, Inc.2010-09-29
All Med Medical 20ga x .75" Winged Administration Set Model # M2075 Reorder # 50-2021 recall (Z-2515-2010)Multi-Med, Inc.2010-09-29
All Med Medical 20ga x .75" Winged Administration Set w/Y Site Model # M2075Y Reorder # 50 recall (Z-2516-2010)Multi-Med, Inc.2010-09-29
All Med Medical 20ga x .75" Standard Bore Winged Administration Set Model # M2075S Reorder recall (Z-2517-2010)Multi-Med, Inc.2010-09-29
All Med Medical 20ga x 1" Winged Administration Set Model # M201 Reorder # 50-2031 recall (Z-2518-2010)Multi-Med, Inc.2010-09-29
All Med Medical 20ga x 1" Winged Administration Set w/Y Site Model # M201Y Reorder # 50-20 recall (Z-2519-2010)Multi-Med, Inc.2010-09-29
All Med Medical 20ga x 1" Standard Bore Winged Administration Set Model # M201S Reorder # recall (Z-2520-2010)Multi-Med, Inc.2010-09-29
All Med Medical 20ga x 1.50" Winged Administration Set Model # M2015 Reorder # 50-2041 recall (Z-2521-2010)Multi-Med, Inc.2010-09-29
All Med Medical 20ga x 1.50" Winged Administration Set w/Y Site Model # M2015Y Reorder # 5 recall (Z-2522-2010)Multi-Med, Inc.2010-09-29
All Med Medical 22ga x .50" Winged Administration Set Model # M225 Reorder # 50-2211 recall (Z-2523-2010)Multi-Med, Inc.2010-09-29
All Med Medical 22ga x .50" Winged Administration Set w/Y Site Model # M225Y Reorder # 50- recall (Z-2524-2010)Multi-Med, Inc.2010-09-29
All Med Medical 22ga x .75" Winged Administration Set Model # M2275 Reorder # 50-2221 recall (Z-2525-2010)Multi-Med, Inc.2010-09-29
All Med Medical 22ga x .75" Winged Administration Set w/Y Site Model # M2275Y Reorder # 50 recall (Z-2526-2010)Multi-Med, Inc.2010-09-29
All Med Medical 22ga x .75" Standard Bore Winged Administration Set Model # M2275S Reorder recall (Z-2527-2010)Multi-Med, Inc.2010-09-29
All Med Medical 22ga x 1" Winged Administration Set Model # M221 Reorder # 50-2231 recall (Z-2528-2010)Multi-Med, Inc.2010-09-29
All Med Medical 22ga x 1" Winged Administration Set w/Y Site Model # M221Y Reorder # 50-22 recall (Z-2529-2010)Multi-Med, Inc.2010-09-29
All Med Medical 22ga x 1" Standard Bore Winged Administration Set Model # M221S Reorder # recall (Z-2530-2010)Multi-Med, Inc.2010-09-29
All Med Medical 22ga x 1.5" Winged Administration Set Model # M2215 Reorder # 50-2241 recall (Z-2531-2010)Multi-Med, Inc.2010-09-29
All Med Medical 22ga x 1.5" Winged Administration Set w/Y Site Model # M2215Y Reorder # 50 recall (Z-2532-2010)Multi-Med, Inc.2010-09-29
All Med Medical 22ga x 1.5" Standard Bore Winged Administration Set Model #M2215S Reorder recall (Z-2533-2010)Multi-Med, Inc.2010-09-29
All Med Medical 19ga x .50" RA Hub Needle Model #M195H Reorder #55-1910 Intended to be use recall (Z-2534-2010)Multi-Med, Inc.2010-09-29
All Med Medical 19ga x .75" RA Hub Needle Model #M1975H Reorder #55-1920 Intended to be us recall (Z-2535-2010)Multi-Med, Inc.2010-09-29
All Med Medical 19ga x 1" RA Hub Needle Model #M191H Reorder #55-1930 Intended to be used recall (Z-2536-2010)Multi-Med, Inc.2010-09-29
All Med Medical 19ga x 1.50" RA Hub Needle Model #M1915H Reorder #55-1940 Intended to be u recall (Z-2537-2010)Multi-Med, Inc.2010-09-29
All Med Medical 20ga x .50" RA Hub Needle Model #M205H Reorder #55-2010 Intended to be use recall (Z-2538-2010)Multi-Med, Inc.2010-09-29
All Med Medical 20ga x .75" RA Hub Needle Model #M2075H Reorder #55-2020 Intended to be us recall (Z-2539-2010)Multi-Med, Inc.2010-09-29
All Med Medical 20ga x 1" RA Hub Needle Model #M201H Reorder #55-2030 Intended to be used recall (Z-2540-2010)Multi-Med, Inc.2010-09-29
All Med Medical 20ga x 1" Straight Hub Needles Model #M201HS Reorder #55-2035 Intended to recall (Z-2541-2010)Multi-Med, Inc.2010-09-29
All Med Medical 20ga x 1.5" RA Hub Needle Model #M2015H Reorder #55-2040 Intended to be us recall (Z-2542-2010)Multi-Med, Inc.2010-09-29
All Med Medical 20ga x 1.5" Straight Hub Needle Model #M2015HS Reorder #55-2045 Intended t recall (Z-2543-2010)Multi-Med, Inc.2010-09-29
All Med Medical 22ga x .50" RA Hub Needle Model #M225H Reorder #55-2210 Intended to be use recall (Z-2544-2010)Multi-Med, Inc.2010-09-29
All Med Medical 22ga x .75" RA Hub Needle Model #M2275H Reorder #55-2220 Intended to be us recall (Z-2545-2010)Multi-Med, Inc.2010-09-29
All Med Medical 22ga x .75" Straight Hub Needle Model #M2275HS Reorder #55-2225 Intended t recall (Z-2546-2010)Multi-Med, Inc.2010-09-29
All Med Medical 22ga x 1" RA Hub Needle Model #M221H Reorder #55-2230 Intended to be used recall (Z-2547-2010)Multi-Med, Inc.2010-09-29
All Med Medical 22ga x 1" Straight Hub Needle Model #M2215HS Reorder #55-2235 Intended to recall (Z-2548-2010)Multi-Med, Inc.2010-09-29
All Med Medical 22ga x 1.50" RA Hub Needle Model #M2215H Reorder #55-2240 Intended to be u recall (Z-2549-2010)Multi-Med, Inc.2010-09-29
All Med Medical 22ga x 1.50" Straight Hub Needle Model #M2215HS Reorder #55-2245 Intended recall (Z-2550-2010)Multi-Med, Inc.2010-09-29
Marquette Medical Huber Trap-A Safety Huber Needle 19ga x 1" Winged Administration Set Mod recall (Z-2551-2010)Multi-Med, Inc.2010-09-29
Marquette Medical Huber Trap-A Safety Huber Needle 19ga x .75" Winged Administration Set M recall (Z-2552-2010)Multi-Med, Inc.2010-09-29
Marquette Medical Huber Trap-A Safety Huber Needle 19ga x .75" Standard Bore Winged Admini recall (Z-2553-2010)Multi-Med, Inc.2010-09-29
Marquette Medical Huber Trap-A Safety Huber Needle 19ga x .75" Winged Administration Set w recall (Z-2554-2010)Multi-Med, Inc.2010-09-29
Marquette Medical Huber Trap-A Safety Huber Needle 19ga x 1" Standard Bore Winged Administ recall (Z-2555-2010)Multi-Med, Inc.2010-09-29