The following data is part of a premarket notification filed by Aci Medical, Llc with the FDA for Artassist And Venassist.
| Device ID | K131146 |
| 510k Number | K131146 |
| Device Name: | ARTASSIST AND VENASSIST |
| Classification | Sleeve, Limb, Compressible |
| Applicant | ACI MEDICAL, LLC 1857 DIAMOND ST San Marcos, CA 92078 |
| Contact | Ed Arkans |
| Correspondent | Ed Arkans ACI MEDICAL, LLC 1857 DIAMOND ST San Marcos, CA 92078 |
| Product Code | JOW |
| CFR Regulation Number | 870.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-04-23 |
| Decision Date | 2014-02-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860446000305 | K131146 | 000 |