The following data is part of a premarket notification filed by Arrow Intl., Inc. with the FDA for Intra-aortic Balloon (iab).
| Device ID | K040801 |
| 510k Number | K040801 |
| Device Name: | INTRA-AORTIC BALLOON (IAB) |
| Classification | System, Balloon, Intra-aortic And Control |
| Applicant | ARROW INTL., INC. 9 PLYMOUTH ST. Everett, MA 02149 |
| Contact | William Paquin |
| Correspondent | William Paquin ARROW INTL., INC. 9 PLYMOUTH ST. Everett, MA 02149 |
| Product Code | DSP |
| CFR Regulation Number | 870.3535 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-03-29 |
| Decision Date | 2004-05-06 |
| Summary: | summary |