The following data is part of a premarket notification filed by Arrow Intl., Inc. with the FDA for Arrow Echogenic Introducer Needle.
| Device ID | K040100 |
| 510k Number | K040100 |
| Device Name: | ARROW ECHOGENIC INTRODUCER NEEDLE |
| Classification | Wire, Guide, Catheter |
| Applicant | ARROW INTL., INC. 2400 BERNVILLE RD. P.O. BOX 12888 Reading, PA 19605 |
| Contact | William G Mclain |
| Correspondent | William G Mclain ARROW INTL., INC. 2400 BERNVILLE RD. P.O. BOX 12888 Reading, PA 19605 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-01-20 |
| Decision Date | 2004-03-01 |
| Summary: | summary |