The following data is part of a premarket notification filed by Arrow Intl., Inc. with the FDA for Arrow Sheathless Intra-aortic Balloon Catheter.
| Device ID | K961358 |
| 510k Number | K961358 |
| Device Name: | ARROW SHEATHLESS INTRA-AORTIC BALLOON CATHETER |
| Classification | System, Balloon, Intra-aortic And Control |
| Applicant | ARROW INTL., INC. 3000 BERNVILLE RD. Reading, PA 19605 |
| Contact | Thomas D Nickel |
| Correspondent | Thomas D Nickel ARROW INTL., INC. 3000 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 | 1996-04-08 |
| Decision Date | 1996-07-02 |