K240972 is an FDA 510(k) clearance for the Medline ReNewal Reprocessed Medtronic Achieve Catheter Connecting Cable (2ACHC). This device is classified as a Catheter, Recording, Electrode, Reprocessed (Class II - Special Controls, product code NLH).
Submitted by Surgical Instrument Service and Savings, Inc. (Redmond, US). The FDA issued a Cleared decision on June 7, 2024, 59 days after receiving the submission on April 9, 2024.
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 | K240972 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 09, 2024 |
| Decision Date | June 07, 2024 |
| Days to Decision | 59 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). |