K771878 is an FDA 510(k) clearance for the IRIDIUM 192 WIRES & PINS. This device is classified as a Source, Wire, Iridium, Radioactive (Class II - Special Controls, product code IWA).
Submitted by Cis Radiopharmaceuticals, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 27, 1977, 23 days after receiving the submission on October 4, 1977.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5730.
| 510(k) Number | K771878 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 04, 1977 |
| Decision Date | October 27, 1977 |
| Days to Decision | 23 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | — |
| Product Code | IWA — Source, Wire, Iridium, Radioactive |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.5730 |