The following data is part of a premarket notification filed by Cormed, Inc., Sub. C.r.bard, Inc. with the FDA for Corcath H & B Vascular Access Catheter.
| Device ID | K823553 |
| 510k Number | K823553 |
| Device Name: | CORCATH H & B VASCULAR ACCESS CATHETER |
| Classification | Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
| Applicant | CORMED, INC., SUB. C.R.BARD, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LJS |
| CFR Regulation Number | 880.5970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-12-01 |
| Decision Date | 1983-01-05 |