The following data is part of a premarket notification filed by Barton-carey Medical Products Co. with the FDA for Vasc-ez.
| Device ID | K854428 |
| 510k Number | K854428 |
| Device Name: | VASC-EZ |
| Classification | Stocking, Medical Support (to Prevent Pooling Of Blood In Legs) |
| Applicant | BARTON-CAREY MEDICAL PRODUCTS CO. P.O. BOX 421 Perrysburg, OH 43551 |
| Contact | John H Mays |
| Correspondent | John H Mays BARTON-CAREY MEDICAL PRODUCTS CO. P.O. BOX 421 Perrysburg, OH 43551 |
| Product Code | DWL |
| CFR Regulation Number | 880.5780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-11-05 |
| Decision Date | 1986-02-13 |