K873597 is an FDA 510(k) clearance for the TUBING, POLYETHYLENE. This device is classified as a Injector And Syringe, Angiographic (Class II - Special Controls, product code DXT).
Submitted by Coeur Laboratories, Inc. (Raleigh, US). The FDA issued a Cleared decision on November 12, 1987, 69 days after receiving the submission on September 4, 1987.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1650.
| 510(k) Number | K873597 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 04, 1987 |
| Decision Date | November 12, 1987 |
| Days to Decision | 69 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DXT — Injector And Syringe, Angiographic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1650 |