Submission Details
| 510(k) Number | K870145 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 13, 1987 |
| Decision Date | March 10, 1987 |
| Days to Decision | 56 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
Cleared
Traditional
EXTERNAL Y VALVE 5C4198
Mar 1987
Decision
56d
Days
Class 2
Risk
About This 510(k) Submission
K870145 is an FDA 510(k) clearance for the EXTERNAL Y VALVE 5C4198, a Set, Administration, For Peritoneal Dialysis, Disposable (Class II — Special Controls, product code KDJ), submitted by Travenol Laboratories, S.A. (Round Lake, US). The FDA issued a Cleared decision on March 10, 1987, 56 days after receiving the submission on January 13, 1987. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5630.
Device Classification
| Product Code | KDJ — Set, Administration, For Peritoneal Dialysis, Disposable |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.5630 |
Manufacturer
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