The following data is part of a premarket notification filed by Arrow Intl., Inc. with the FDA for Arrow Echogenic Introducer Needle Component.
| Device ID | K071998 |
| 510k Number | K071998 |
| Device Name: | ARROW ECHOGENIC INTRODUCER NEEDLE COMPONENT |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | ARROW INTL., INC. P.O. BOX 12888 Reading, PA 19612 -2888 |
| Contact | Kirsten Stowell |
| Correspondent | Kirsten Stowell ARROW INTL., INC. P.O. BOX 12888 Reading, PA 19612 -2888 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-07-23 |
| Decision Date | 2007-09-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20801902100911 | K071998 | 000 |
| 30801902191985 | K071998 | 000 |
| 20801902214953 | K071998 | 000 |
| 30801902211249 | K071998 | 000 |
| 20801902003199 | K071998 | 000 |
| 20801902024507 | K071998 | 000 |
| 20801902025054 | K071998 | 000 |
| 20801902098157 | K071998 | 000 |
| 20801902100904 | K071998 | 000 |
| 20801902218449 | K071998 | 000 |