K910154 is an FDA 510(k) clearance for the USCI ILLUMEN-8 8F PTCA GUIDING CATHETER. This device is classified as a Radioimmunoassay, Digoxin (3-h), Goat Antibody, 2nd Antibody Sep. (Class II - Special Controls, product code DOY).
Submitted by C.R. Bard, Inc. (Billerica, US). The FDA issued a Cleared decision on April 9, 1991, 85 days after receiving the submission on January 14, 1991.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3320.
| 510(k) Number | K910154 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 14, 1991 |
| Decision Date | April 09, 1991 |
| Days to Decision | 85 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | — |
| Product Code | DOY — Radioimmunoassay, Digoxin (3-h), Goat Antibody, 2nd Antibody Sep. |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3320 |