Atlas FDA

MODIFIED ARGYLE POLYURETHANE UMBILICAL VESSEL CATHETER 2.5FR, 3.5FR, 5 FR.

FDA 510(k) clearance K130725 · decided 2013-04-17

Clearance details

K-number
K130725
Device name
MODIFIED ARGYLE POLYURETHANE UMBILICAL VESSEL CATHETER 2.5FR, 3.5FR, 5 FR.
Applicant
Covidien Lp, Formerly Registered AS Kendall
Decision
Substantially Equivalent
Date received
2013-03-18
Decision date
2013-04-17
Days to decision
30 days
Clearance type
Special
Product code
FOS
Device class
2
Regulation number
880.5200
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
Mansfield, MA, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Umbilical Vessels Catheter (K201697)Haolang Medical USA Corporation2021-05-06
FOOTPRINT MEDICAL POLYURETHANE UMBILICAL CATHETER (K120304)Footprint Medical, Inc.2012-03-01
FOOTPRINT MEDICAL SILICONE UMBILICAL CATHETER (K091214)Footprint Medical2009-09-25
FOOTPRINT MEDICAL UMBILICAL CATHETER, DUAL LUMEN (K091213)Footprint Medical2009-09-25
NEOMED DUAL LUMEN UMBILICAL CATHETER, MODELS S2UVC4.0, S2UVC5.0 (K081515)Neomed, Inc.2008-07-21
NEOMED SINGLE LUMEN UMBILICAL CATHETER (K073596)Neomed, Inc.2008-02-22
VYGON DOUBLE LUMEN UMBILICAL CATHETER (K981630)Schiff & Co.1998-10-01
NEO-CARE DUAL LUMEN UMBILICAL CATHETER (K963972)Klein-Baker Medical, Inc.1996-12-24
ARGYLE NEO-SERT HYDROPHILIC POLYURETHANE UMBILICAL VESSEL CATHETER INSERTION TRAY (K954300)Sherwood Medical Co.1995-12-13
ARGYLE NEO-SERT TRIPLE LUMEN UMBILICAL VESSEL CATHETER (K951738)Sherwood Medical Co.1995-09-29
ARGYLE NEO-SERT TRIPLE LUMEN UMBILICAL VESSEL CATHETER INSERTION TRAY (K951737)Sherwood Medical Co.1995-09-28
CENTURION UMBILICAL CATHETER (K942353)Tri-State Hospital Supply Corp.1995-08-15

Recalls involving this device

RecordFirmDate
Catalog No. 8888160325; Umbilical Vessel Catheter 2.5 French single lumen recall (Z-1871-2025)Cardinal Health 200, LLC2025-05-29
Catalog No. 8888160333; Umbilical Vessel Catheter 3.5 French single lumen recall (Z-1872-2025)Cardinal Health 200, LLC2025-05-29
Catalog No. 8888160341; Umbilical Vessel Catheter 5 French single lumen recall (Z-1873-2025)Cardinal Health 200, LLC2025-05-29