K112292 is an FDA 510(k) clearance for the REPROCESSED 2515 NAV VARIABLE ELECTROPHYSIOLOGY CATHETER. This device is classified as a Catheter, Recording, Electrode, Reprocessed (Class II - Special Controls, product code NLH).
Submitted by Stryker Sustainability Solutions (Tempe, US). The FDA issued a Cleared decision on October 21, 2011, 72 days after receiving the submission on August 10, 2011.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1220. Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission. (70 Fr 56911, Available At Https://www.govinfo.gov/content/pkg/fr-2005-09-29/pdf/05-19510.pdf)..
| 510(k) Number | K112292 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 10, 2011 |
| Decision Date | October 21, 2011 |
| Days to Decision | 72 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | NLH — Catheter, Recording, Electrode, Reprocessed |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1220 |
| Definition | Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission. (70 Fr 56911, Available At Https://www.govinfo.gov/content/pkg/fr-2005-09-29/pdf/05-19510.pdf). |