Atlas FDA

VECTORFLOW; ANTEGRADE CHRONIC HEMODIALYSIS CATHETER, RETROGRADE CHRONIC HEMODIALYSIS CATHETER, RETROGRADE REPLACEMENT HU

FDA 510(k) clearance K141051 · decided 2014-07-07

Clearance details

K-number
K141051
Device name
VECTORFLOW; ANTEGRADE CHRONIC HEMODIALYSIS CATHETER, RETROGRADE CHRONIC HEMODIALYSIS CATHETER, RETROGRADE REPLACEMENT HU
Applicant
Arrow International, Inc.
Decision
Substantially Equivalent
Date received
2014-04-24
Decision date
2014-07-07
Days to decision
74 days
Clearance type
Special
Product code
MSD
Device class
2
Regulation number
876.5540
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Reading, PA, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Arrow International

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

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
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

Recalls involving this device

RecordFirmDate
Arrow-Clark VectorFlow Antegrade Chronic Hemodialysis Catheter: REF: ACS-15192-VFI, ACS-15 recall (Z-2157-2026)ARROW INTERNATIONAL, LLC2026-05-13