The following data is part of a premarket notification filed by Arrow Intl., Inc. with the FDA for Iab-04840-u;iab-04250-u;iab-04240-u;iab-04230-u.
| Device ID | K970689 |
| 510k Number | K970689 |
| Device Name: | IAB-04840-U;IAB-04250-U;IAB-04240-U;IAB-04230-U |
| Classification | System, Balloon, Intra-aortic And Control |
| Applicant | ARROW INTL., INC. 2400 BERNVILLE RD. Reading, PA 19605 |
| Contact | Thomas D Nickel |
| Correspondent | Thomas D Nickel ARROW INTL., INC. 2400 BERNVILLE RD. Reading, PA 19605 |
| Product Code | DSP |
| CFR Regulation Number | 870.3535 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-25 |
| Decision Date | 1998-06-04 |
| Summary: | summary |