The following data is part of a premarket notification filed by Arteria Medical Science, Inc. with the FDA for Arteria Occlusion Balloon.
| Device ID | K021210 |
| 510k Number | K021210 |
| Device Name: | ARTERIA OCCLUSION BALLOON |
| Classification | Catheter, Intravascular Occluding, Temporary |
| Applicant | ARTERIA MEDICAL SCIENCE, INC. 22 HILL ST. Newburyport, MA 01950 |
| Contact | Alan Hinton |
| Correspondent | Alan Hinton ARTERIA MEDICAL SCIENCE, INC. 22 HILL ST. Newburyport, MA 01950 |
| Product Code | MJN |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-04-17 |
| Decision Date | 2002-10-28 |
| Summary: | summary |