The following data is part of a premarket notification filed by Arrow Intl., Inc. with the FDA for New Hydrophilic Coating For Wire Guides.
| Device ID | K924385 |
| 510k Number | K924385 |
| Device Name: | NEW HYDROPHILIC COATING FOR WIRE GUIDES |
| Classification | Wire, Guide, Catheter |
| Applicant | ARROW INTL., INC. P.O. BOX 12888 3000 BERNVILLE RD Reading, PA 19612 |
| Contact | Thomas D Nickel |
| Correspondent | Thomas D Nickel ARROW INTL., INC. P.O. BOX 12888 3000 BERNVILLE RD Reading, PA 19612 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-08-24 |
| Decision Date | 1993-08-15 |