Reprocessed Steerable Introducer— 510(k) K152090

Name: FDA 510(k) clearance K152090
Creator: U.S. Food and Drug Administration
Published: 2016-03-23

Substantially Equivalent

Sterilmed, Inc.

FDA 510(k) clearance K152090 for Reprocessed Steerable Introducer, Substantially Equivalent on 2016-03-23. Applicant: Sterilmed, Inc.. Device class: 2.

Clearance details

Applicant: Sterilmed, Inc.
Product code: Code PNE
Device class: Class 2
Regulation: 21 CFR 870.1340
Advisory panel: Cardiovascular
Date received: 2015-07-27
Decision date: 2016-03-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plymouth, MN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code PNE

view all

K250305 — Reprocessed Agilis NxT Steerable Introducer2026-01-07
K250314 — Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable Introducer2025-12-19
K232037 — Reprocessed VersaCross Steerable Sheath; Reprocessed SureFlex Steerable Guiding Sheath2024-04-04
K230376 — Reprocessed Agilis NxT Steerable Introducer2023-08-07
K212165 — Reprocessed Carto Vizigo Bi-Directional Guiding Sheath2022-03-10

More clearances from Sterilmed, Inc.

view all

K254149 — Reprocessed AcuNav CRYSTAL Ultrasound Catheter 9F x 90 CM, For Use on Siemens System (R11510825) +3 more2026-06-29
K240826 — Reprocessed DECANAV Electrophysiology Catheter; Reprocessed WEBSTER® Duo-Decapolar Electrophysiology Catheter2024-10-11
K190478 — Reprocessed ViewFlex Xtra ICE Catheter2019-11-14
K190610 — Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology2019-08-15
K182272 — Reprocessed HARMONIC ACE+ 7 Shears with Advanced Hemostasis2019-04-15

Recalls naming K152090

K-number listed on FDA's recall record

Z-0090-2019 — Reprocessed Agilis Steerable Introducer: indicated for introducing various cardiovascular catheters into the heart. (a) small curl (16.8mm curve type/71 cm length), Product Code STJ408309; (b) medium curl (22.4 mm curve type/71 cm length), Product Code STJ408310; (c) large curl (50 mm curve type/71 cm length), Product Code STJ408324Class II·Terminated·Sterilmed, Inc.·20180917
Z-0213-2018 — St. Jude Medical. Agilis NxT Steerable Introducer: B1-Directional, Medium Curl 22.4 mm, 71 cm, 6.5 F ID; Dilator: 94 cm, 8.5 F; Super Stiff, Guidewire: 180 cm, 0.032". Reprocessed device for single use only, sterile. Product Usage: The reprocessed steerable introducer sheaths are indicated when introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.Class I·Terminated·Sterilmed Inc·20170602

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K152090.

Data sourced from openFDA. This site is unofficial and independent of the FDA.