K761161 is an FDA 510(k) clearance for the 67-8006 DARLING-LINTON AORTIC TOURN.. This device is classified as a Instruments, Surgical, Cardiovascular (Class I - General Controls, product code DWS).
Submitted by Codman & Shurtleff, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 6, 1976, 7 days after receiving the submission on November 29, 1976.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4500.
| 510(k) Number | K761161 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 29, 1976 |
| Decision Date | December 06, 1976 |
| Days to Decision | 7 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | - |
| Product Code | DWS - Instruments, Surgical, Cardiovascular |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 870.4500 |