Atlas FDA

INTRAVENOUS EXTENSION SET

FDA 510(k) clearance K895367 · decided 1989-10-06

Clearance details

K-number
K895367
Device name
INTRAVENOUS EXTENSION SET
Applicant
Medical Product Specialists
Decision
Substantially Equivalent
Date received
1989-08-28
Decision date
1989-10-06
Days to decision
39 days
Clearance type
Traditional
Product code
FPA
Device class
2
Regulation number
880.5440
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
Irvine, CA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Brand Name: Medela Product Name: ENFit ExSet Strl 60 2.0ml PV 1ct EN Model/Catalog Number: recall (Z-2645-2026)Medela Inc2026-07-01
Acacia Catalog # 385150 IV Extension Set 15cm Small Bore, Spin Nut w/BD Q-Syte recall (Z-1076-2010)Medical Product Specialist Inc dba MPS Acacia2010-03-30
Acacia Catalog # 385151 IV Extension Set 15cm Small Bore, Spin Nut w/BD Q-Syte recall (Z-1077-2010)Medical Product Specialist Inc dba MPS Acacia2010-03-30
Acacia Catalog # 385164 Tri-Extension IV Set 15cm Small Bore, Spin Nut w/BD Q-Syte recall (Z-1078-2010)Medical Product Specialist Inc dba MPS Acacia2010-03-30
Acacia Catalog # 385165 "Y" IV Extension Set 20cm Macro Bore, Spin Nut w/BD Q-Syte recall (Z-1079-2010)Medical Product Specialist Inc dba MPS Acacia2010-03-30
Acacia Catalog # 385166 Dual "Y" IV Extension Set 50cm Macro Bore, Spin Nut w/BD Q-Syte recall (Z-1080-2010)Medical Product Specialist Inc dba MPS Acacia2010-03-30