Arrow Intl., Inc. · Class II · Cleared Sep 16, 1997
| K-number | K963865 |
| Device name | 8 FR. -30CC NARROWFLEX SHEATHLESS INTRA-AORTIC BALLOON CATHETER, PRODUCT NUMBER IAB-04830S |
| Applicant | Arrow Intl., Inc. |
| Product code | DSP |
| Device class | Class II |
| Decision date | Sep 16, 1997 |
| Decision | Substantially Equivalent |
| Regulation | 870.3535 |
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