Atlas FDA

SPLIT CATH RG

FDA 510(k) clearance K130889 · decided 2014-04-28

Clearance details

K-number
K130889
Device name
SPLIT CATH RG
Applicant
Medcomp
Decision
Unknown
Date received
2013-03-29
Decision date
2014-04-28
Days to decision
395 days
Clearance type
Traditional
Product code
MSD
Device class
2
Regulation number
876.5540
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Harleysville, PA, US
Third-party review
No
Expedited review
No

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15.5F X 19 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 23 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 28 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 33 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 37 cm Symetrex Long Term Hemodialysis Catheter with Sideholes (K173667)Medical Components, Inc. (dba MedComp)2018-05-17
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Recalls involving this device

No recalls on record reference this clearance.