The following data is part of a premarket notification filed by Burron Medical Products, Inc. with the FDA for Cavafix(r) Central Venous Catheter Kit W/suture.
| Device ID | K870403 |
| 510k Number | K870403 |
| Device Name: | CAVAFIX(R) CENTRAL VENOUS CATHETER KIT W/SUTURE |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | BURRON MEDICAL PRODUCTS, INC. 824 TWELFTH AVE. Bethlehem, PA 18018 |
| Contact | Tracey Connolly |
| Correspondent | Tracey Connolly BURRON MEDICAL PRODUCTS, INC. 824 TWELFTH AVE. Bethlehem, PA 18018 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-02-02 |
| Decision Date | 1987-05-01 |