The following data is part of a premarket notification filed by Buckman Co., Inc. with the FDA for Intra-art(tm) Internal Mammary Infusion Catheter.
| Device ID | K882034 |
| 510k Number | K882034 |
| Device Name: | INTRA-ART(TM) INTERNAL MAMMARY INFUSION CATHETER |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | BUCKMAN CO., INC. 921 CALLE VERDE Martinez, CA 94553 |
| Contact | David W Schlerf |
| Correspondent | David W Schlerf BUCKMAN CO., INC. 921 CALLE VERDE Martinez, CA 94553 |
| Product Code | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-05-16 |
| Decision Date | 1988-07-28 |