The following data is part of a premarket notification filed by Microtek Medical, Inc. with the FDA for Venodyne Dvt Advantage Plus.
| Device ID | K011318 |
| 510k Number | K011318 |
| Device Name: | VENODYNE DVT ADVANTAGE PLUS |
| Classification | Sleeve, Limb, Compressible |
| Applicant | MICROTEK MEDICAL, INC. 512 LEHMBERG RD. Columbus, MS 39702 |
| Contact | Tom Bonner |
| Correspondent | Tom Bonner MICROTEK MEDICAL, INC. 512 LEHMBERG RD. Columbus, MS 39702 |
| Product Code | JOW |
| CFR Regulation Number | 870.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-05-01 |
| Decision Date | 2001-10-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50748426120685 | K011318 | 000 |
| 50748426105804 | K011318 | 000 |
| 50748426076845 | K011318 | 000 |
| 50748426069892 | K011318 | 000 |
| 50748426062671 | K011318 | 000 |
| 50748426062664 | K011318 | 000 |