The following data is part of a premarket notification filed by Burron Medical Products, Inc. with the FDA for Burron Central Vein Catherization Kit.
| Device ID | K810461 |
| 510k Number | K810461 |
| Device Name: | BURRON CENTRAL VEIN CATHERIZATION KIT |
| Classification | Catheter, Percutaneous |
| Applicant | BURRON MEDICAL PRODUCTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-02-20 |
| Decision Date | 1981-03-11 |