K904435 is an FDA 510(k) clearance for the VENTROFIL TENSION RELIEF SUTURE SET. This device is classified as a Retention Device, Suture (Class I - General Controls, product code KGS).
Submitted by Aesculap, Inc. (Burlingame, US). The FDA issued a Cleared decision on August 29, 1991, 335 days after receiving the submission on September 28, 1990.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4930.
| 510(k) Number | K904435 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 28, 1990 |
| Decision Date | August 29, 1991 |
| Days to Decision | 335 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | KGS — Retention Device, Suture |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4930 |