Submission Details
| 510(k) Number | K152090 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 27, 2015 |
| Decision Date | March 23, 2016 |
| Days to Decision | 240 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
Reprocessed Steerable Introducer
Mar 2016
Decision
240d
Days
Class 2
Risk
About This 510(k) Submission
K152090 is an FDA 510(k) clearance for the Reprocessed Steerable Introducer, a Reprocessed Catheter Introducer (Class II — Special Controls, product code PNE), submitted by Sterilmed, Inc. (Plymouth, US). The FDA issued a Cleared decision on March 23, 2016, 240 days after receiving the submission on July 27, 2015. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1340.
Device Classification
| Product Code | PNE — Reprocessed Catheter Introducer |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.1340 |
| Definition | Introduce Various Cardiovascular Catheters Into The Heart And Cardiovascular System |
Manufacturer
Similar Devices — PNE Reprocessed Catheter Introducer
K250305 · Innovative Health
· Jan 2026
K250314 · Surgical Instrument Service and Savings, Inc.
· Dec 2025
K232037 · Innovative Health, LLC
· Apr 2024
K230376 · Innovative Health, LLC
· Aug 2023
K212165 · Innovative Health, LLC
· Mar 2022
K170311 · Innovative Health, LLC
· Jun 2017
More from Sterilmed, Inc.
View all
K240826
· NLH · Oct 2024
K190478
· OWQ · Nov 2019
K190610
· NLQ · Aug 2019
K182272
· NLQ · Apr 2019
K161700
· OWQ · Nov 2016