K990348 is an FDA 510(k) clearance for the WALLACE TRIAL TRANSFER CATHETER, MODEL TT 1816N, a Catheter, Assisted Reproduction (Class II — Special Controls, product code MQF), submitted by CooperSurgical, Inc. (Shelton, US). The FDA issued a Cleared decision on July 26, 1999, 171 days after receiving the submission on February 5, 1999. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.6110.
| 510(k) Number | K990348 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 05, 1999 |
| Decision Date | July 26, 1999 |
| Days to Decision | 171 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | MQF — Catheter, Assisted Reproduction |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.6110 |