Nextstep Retrograde

FDA 510(k) K130192 · Arrow International, Inc.

Unknown

510(k) numberK130192

Submission

Device name
Nextstep Retrograde
Applicant
Arrow International, Inc.
Reading, PA, US
Received
January 25, 2013
Decision date
May 10, 2013
Decision
Unknown (SESK)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MSD – Catheter, Hemodialysis, Implanted
Device class
Class II (moderate risk)
Regulation
21 CFR 876.5540
Specialty
Gastroenterology, Urology
Implant
Yes
Life-sustaining
Yes

Other 510(k)s with product code MSD

510(k)DeviceApplicantDecision
K241581Hemodialysis CatheterMSD · Traditional Haolang Medical USA Corporation05/16/2025SESK
K210461End CapMSD · Traditional Medical Components Inc (Medcomp)09/14/2021SE
K203575GlidePath Retro Long-Term Hemodialysis CatheterMSD · Traditional C.R. Bard, Inc.07/01/2021SESK
K211410GlidePath 13F Long-Term Hemodialysis CatheterMSD · Special Bard Peripheral Vascular, Inc.06/04/2021SESK
K203767Pristine Long-Term Hemodialysis CatheterMSD · Traditional C B Bard, Inc.04/02/2021SESK
K202150GlidePath 7.5F Long-Term Dialysis CatheterMSD · Traditional C.R. Bard, Inc.11/18/2020SESK
K202176Symetrex LTHD Catheter, Symetrex LTHD Catheter with SideholesMSD · Special Medical Components, Inc. (dba MedComp)09/03/2020SE
K200627GlidePath 10F Long-Term Dialysis CatheterMSD · Traditional C.R. Bard, Inc.06/22/2020SESK
K190527GlidePath Long-Term Hemodialysis Catheters, HemoStar Long-Term Hemodialysis Catheters…MSD · Traditional C. R. Bard03/05/2020SESK
K182443Pristine Hemodialysis CatheterMSD · Traditional Pristine Access Technologies , Ltd.05/31/2019SE

More from Pristine Access Technologies , Ltd.

510(k)DeviceDecision
K250542AC3™ Range™ Intra-Aortic Balloon PumpDSP · Special 03/26/2025SE
K232343AC3™ Series IABPDSP · Special 08/30/2023SE
K222341Arrow 0.2 Micron Flat Filter, GVSCAZ · Traditional 02/13/2023SE
K201112AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABPDSP · Special 05/27/2020SE
K200634Arrow FiberOptix Intra-Aortic Balloon Catheter KitDSP · Special 04/09/2020SE
K190101UltraFlex IABDSP · Traditional 06/28/2019SE
K190117Fiberoptix IABDSP · Traditional 06/13/2019SE
K162820AC3 Series IABP SystemDSP · Traditional 03/31/2017SE
K141051Vectorflow; Antegrade Chronic Hemodialysis Catheter, Retrograde Chronic Hemodialysis…MSD · Special 07/07/2014SE
K130876Cg+ Arrow Picc Powered by Arrow VPS StyletLJS · Special 04/26/2013SE

Questions and answers

When was Nextstep Retrograde cleared by the FDA?

Nextstep Retrograde (K130192) received a 510(k) decision of Unknown on May 10, 2013, 105 days after the submission was received.

What is the product code of K130192?

The FDA product code is MSD – Catheter, Hemodialysis, Implanted, a Class II (moderate risk) device regulated under 21 CFR 876.5540.