K152090 is an FDA 510(k) clearance for the Reprocessed Steerable Introducer. This device is classified as 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 FDA review panel. Regulated under 21 CFR 870.1340. Introduce Various Cardiovascular Catheters Into The Heart And Cardiovascular System.
| 510(k) Number | K152090 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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 |
| 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 |