The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Usci Illumen-8 8f Ptca Guiding Catheter.
| Device ID | K910154 |
| 510k Number | K910154 |
| Device Name: | USCI ILLUMEN-8 8F PTCA GUIDING CATHETER |
| Classification | Radioimmunoassay, Digoxin (3-h), Goat Antibody, 2nd Antibody Sep. |
| Applicant | C.R. BARD, INC. 1200 TECHNOLOGY PARK DR. P.O. BOX 7025 Billerica, MA 01821 |
| Contact | Janet D Benson |
| Correspondent | Janet D Benson C.R. BARD, INC. 1200 TECHNOLOGY PARK DR. P.O. BOX 7025 Billerica, MA 01821 |
| Product Code | DOY |
| CFR Regulation Number | 862.3320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-01-14 |
| Decision Date | 1991-04-09 |