Atlas FDA

NAMIC CONTRAST & FLUID DELIVERY SPIKES(VARIOUS)

FDA 510(k) clearance K852140 · decided 1985-05-30

Clearance details

K-number
K852140
Device name
NAMIC CONTRAST & FLUID DELIVERY SPIKES(VARIOUS)
Applicant
North American Instrument Corp.
Decision
Substantially Equivalent
Date received
1985-05-16
Decision date
1985-05-30
Days to decision
14 days
Clearance type
Traditional
Product code
FPA
Device class
2
Regulation number
880.5440
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
NY, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Medline Fluid Delivery Set with Drip Chamber: 1) FDS,135,CHMN,W/F,MLL,RC(2),PG, Item Numbe recall (Z-0764-2025)MEDLINE INDUSTRIES, LP - Northfield2025-01-15
Namic FLUID DELIVERY SET, REF 91300040 recall (Z-1807-2024)MEDLINE INDUSTRIES, LP - Northfield2024-05-10
NAMIC Fluid Delivery Set - 72" (183cm) UPN H965913000051, Catalog 91300005 recall (Z-1853-2017)Angiodynamics Inc. (Navilyst Medical Inc.)2017-03-29