Atlas FDA

End Cap

FDA 510(k) clearance K210461 · decided 2021-09-14

Clearance details

K-number
K210461
Device name
End Cap
Applicant
Medical Components Inc (Medcomp)
Decision
Substantially Equivalent
Date received
2021-02-16
Decision date
2021-09-14
Days to decision
210 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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Similar devices under this product code

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RecordFirmDate
Hemodialysis Catheter (K241581)Haolang Medical USA Corporation2025-05-16
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GlidePath 7.5F Long-Term Dialysis Catheter (K202150)C.R. Bard, Inc.2020-11-18
Symetrex LTHD Catheter, Symetrex LTHD Catheter with Sideholes (K202176)Medical Components, Inc. (dba MedComp)2020-09-03
GlidePath 10F Long-Term Dialysis Catheter (K200627)C.R. Bard, Inc.2020-06-22
GlidePath Long-Term Hemodialysis Catheters, HemoStar Long-Term Hemodialysis Catheters, HemoStar XK Long-Term Hemodialysis Catheters (K190527)C. R. Bard2020-03-05
Pristine Hemodialysis Catheter (K182443)Pristine Access Technologies , Ltd.2019-05-31
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
NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (19cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (23cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (27cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (31cm),NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (35cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (55cm) (K173805)Marvao Medical Devices, Ltd.2018-02-08
NexSite HD, Hemodialysis Step Tip Catheter (60cm) (K171571)Marvao Medical Devices, Ltd.2017-11-30

Recalls involving this device

No recalls on record reference this clearance.