The following data is part of a premarket notification filed by Burron Medical Products, Inc. with the FDA for Cavafix, Central Venous Catheter Kit.
| Device ID | K861479 |
| 510k Number | K861479 |
| Device Name: | CAVAFIX, CENTRAL VENOUS CATHETER KIT |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | BURRON MEDICAL PRODUCTS, INC. 824 TWELFTH AVE. Bethlehem, PA 18018 |
| Contact | Tracey Yakabow |
| Correspondent | Tracey Yakabow BURRON MEDICAL PRODUCTS, INC. 824 TWELFTH AVE. Bethlehem, PA 18018 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent - With Drug (SESD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-04-22 |
| Decision Date | 1986-07-01 |