Atlas FDA

Pristine Hemodialysis Catheter

FDA 510(k) clearance K182443 · decided 2019-05-31

Clearance details

K-number
K182443
Device name
Pristine Hemodialysis Catheter
Applicant
Pristine Access Technologies , Ltd.
Decision
Substantially Equivalent
Date received
2018-09-07
Decision date
2019-05-31
Days to decision
266 days
Clearance type
Traditional
Product code
MSD
Device class
2
Regulation number
876.5540
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Tel-Aviv, IL
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
Hemodialysis Catheter (K241581)Haolang Medical USA Corporation2025-05-16
End Cap (K210461)Medical Components Inc (Medcomp)2021-09-14
GlidePath Retro Long-Term Hemodialysis Catheter (K203575)C.R. Bard, Inc.2021-07-01
GlidePath 13F Long-Term Hemodialysis Catheter (K211410)Bard Peripheral Vascular, Inc.2021-06-04
Pristine Long-Term Hemodialysis Catheter (K203767)C B Bard, Inc.2021-04-02
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
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.