PNEClass II
Reprocessed Catheter Introducer
Cardiovascular · 21 CFR 870.1340
Introduce various cardiovascular catheters into the heart and cardiovascular system
MDR events27All time
Recalls0All time
Registered firms8Currently listed
510(k) clearances7All time
Recent MDR events
27 adverse event reports on file
- N/AJul 31, 2026MalfunctionInnovative Health, Llc.3011610434-2026-00015
- N/AJul 10, 2026MalfunctionInnovative Health, Llc.3011610434-2026-00013
- N/AJun 12, 2026MalfunctionInnovative Health, Llc.3011610434-2026-00012
- N/AJun 1, 2026MalfunctionInnovative Health, Llc.3011610434-2026-00010
- N/AMay 4, 2026MalfunctionInnovative Health, Llc.3011610434-2026-00009
- N/AApr 11, 2026MalfunctionInnovative Health, Llc.3011610434-2026-00008
- N/AApr 10, 2026MalfunctionInnovative Health, Llc.3011610434-2026-00006
- N/AApr 10, 2026MalfunctionInnovative Health, Llc.3011610434-2026-00007
- N/AMar 25, 2026MalfunctionInnovative Health, Llc.3011640434-2026-00004
- N/AFeb 27, 2026MalfunctionInnovative Health, Llc.3011610434-2026-00003
Event type breakdown
Malfunction27
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
8 firms currently registered for this product code
510(k) clearances
7 clearances for this product code
- Innovative HealthJan 7, 2026
K250305 · Reprocessed Agilis NxT Steerable Introducer
- Surgical Instrument Service and Savings, Inc.Dec 19, 2025
K250314 · Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable Introducer
- Innovative Health, LLCApr 4, 2024
K232037 · Reprocessed VersaCross Steerable Sheath; Reprocessed SureFlex Steerable Guiding Sheath
- Innovative Health, LLCAug 7, 2023
K230376 · Reprocessed Agilis NxT Steerable Introducer
- Innovative Health, LLCMar 10, 2022
K212165 · Reprocessed Carto Vizigo Bi-Directional Guiding Sheath
- Innovative Health, LLCJun 2, 2017
K170311 · Reprocessed Agilis NxT Steerable Introducer
- Sterilmed, Inc.Mar 23, 2016
K152090 · Reprocessed Steerable Introducer