The following data is part of a premarket notification filed by Bio Compression Systems, Inc. with the FDA for Bioarterial Plus, Arterial Blood Flow Enhancement System.
| Device ID | K072666 |
| 510k Number | K072666 |
| Device Name: | BIOARTERIAL PLUS, ARTERIAL BLOOD FLOW ENHANCEMENT SYSTEM |
| Classification | Sleeve, Limb, Compressible |
| Applicant | BIO COMPRESSION SYSTEMS, INC. P.O. BOX 470218 Broadview Heights, OH 44141 |
| Contact | James Jochen Rogers |
| Correspondent | Daniel W Lehtonen INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | JOW |
| CFR Regulation Number | 870.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2007-09-21 |
| Decision Date | 2007-11-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00812311021205 | K072666 | 000 |
| 00812311021199 | K072666 | 000 |