The following data is part of a premarket notification filed by Cormed, Inc., Sub. C.r.bard, Inc. with the FDA for Percutaneous Introducer Kit.
| Device ID | K860432 |
| 510k Number | K860432 |
| Device Name: | PERCUTANEOUS INTRODUCER KIT |
| Classification | Introducer, Catheter |
| Applicant | CORMED, INC., SUB. C.R.BARD, INC. 591 MAHAR ST. Medina, NY 14103 |
| Contact | Eric P Ankerud |
| Correspondent | Eric P Ankerud CORMED, INC., SUB. C.R.BARD, INC. 591 MAHAR ST. Medina, NY 14103 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-02-04 |
| Decision Date | 1986-03-31 |