K912645 is an FDA 510(k) clearance for the ATRIUMS PDR THORACIC CATHETER, a Catheter, Ventricular, General & Plastic Surgery (Class I — General Controls, product code GBS), submitted by Atrium Medical Corp. (Hollis, US). The FDA issued a Cleared decision on September 13, 1991, 88 days after receiving the submission on June 17, 1991. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4200.
| 510(k) Number | K912645 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 17, 1991 |
| Decision Date | September 13, 1991 |
| Days to Decision | 88 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | GBS — Catheter, Ventricular, General & Plastic Surgery |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 878.4200 |