K063844 is an FDA 510(k) clearance for the REPROCESSED HEART STABILIZERS AND POSITIONERS. This device is classified as a Stabilizer, Heart, Non-compression, Reprocessed (Class I - General Controls, product code NQG).
Submitted by Sterilmed, Inc. (Maple Grove, US). The FDA issued a Cleared decision on March 15, 2007, 79 days after receiving the submission on December 26, 2006.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4500. The Device Is Used To Stabilize, Move, Lift, And Position The Heart During Cardiovascular Surgery. 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 | K063844 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 26, 2006 |
| Decision Date | March 15, 2007 |
| Days to Decision | 79 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | NQG — Stabilizer, Heart, Non-compression, Reprocessed |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 870.4500 |
| Definition | The Device Is Used To Stabilize, Move, Lift, And Position The Heart During Cardiovascular Surgery. 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). |