The following data is part of a premarket notification filed by Arrow Intl., Inc. with the FDA for Arrow-trerotola Ptd Catheter.
| Device ID | K970080 |
| 510k Number | K970080 |
| Device Name: | ARROW-TREROTOLA PTD CATHETER |
| Classification | Catheter, Peripheral, Atherectomy |
| 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 | MCW |
| CFR Regulation Number | 870.4875 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-01-09 |
| Decision Date | 1997-07-25 |
| Summary: | summary |