K852642 is an FDA 510(k) clearance for the CENTRAL VEIN CATHETERIZATION TRAY. This device is classified as a Attachment, Eyepiece, For Insertion Of Prescription Lens (Class I - General Controls, product code FDZ).
Submitted by Teleflexmedical, Inc. (Jeffrey, US). The FDA issued a Cleared decision on January 16, 1986, 209 days after receiving the submission on June 21, 1985.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K852642 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 21, 1985 |
| Decision Date | January 16, 1986 |
| Days to Decision | 209 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | FDZ — Attachment, Eyepiece, For Insertion Of Prescription Lens |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 876.1500 |