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510(k) K152090

Device
Reprocessed Steerable Introducer
Applicant
STERILMED, INC.
510(k) number
K152090
Product code
PNE  
Decision
Substantially Equivalent (SESE)
Decision date
2016-03-23
Date received
2015-07-27
Regulation
870.1340
Classification name
Reprocessed Catheter Introducer
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Patricia Kaufman
Address
5010 Cheshire Pkwy. N. Suite 2 Plymouth MN US 55446 55446

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code PNE  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K250305Reprocessed Agilis NxT Steerable IntroducerInnovative Health2026-01-07
K250314Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable IntroducerSurgical Instrument Service and Savings, Inc.2025-12-19
K232037Reprocessed VersaCross Steerable Sheath; Reprocessed SureFlex Steerable Guiding SheathInnovative Health, LLC2024-04-04
K230376Reprocessed Agilis NxT Steerable IntroducerInnovative Health, LLC2023-08-07
K212165Reprocessed Carto Vizigo Bi-Directional Guiding SheathInnovative Health, LLC2022-03-10
K170311Reprocessed Agilis NxT Steerable IntroducerInnovative Health, LLC2017-06-02

Legacy Summary#

summary

FDA Review#

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