The following data is part of a premarket notification filed by Arrow Intl., Inc. with the FDA for Introducer Safety Syringe.
| Device ID | K884490 |
| 510k Number | K884490 |
| Device Name: | INTRODUCER SAFETY SYRINGE |
| Classification | Wire, Guide, Catheter |
| Applicant | ARROW INTL., INC. P.O. BOX 6306 HILL AND GEORGE AVENUES Reading, PA 19610 |
| Contact | Thomas D Nickel |
| Correspondent | Thomas D Nickel ARROW INTL., INC. P.O. BOX 6306 HILL AND GEORGE AVENUES Reading, PA 19610 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-10-26 |
| Decision Date | 1989-01-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20801902098188 | K884490 | 000 |
| 20801902097921 | K884490 | 000 |
| 20801902007258 | K884490 | 000 |
| 30801902003134 | K884490 | 000 |
| 20801902195085 | K884490 | 000 |
| 30801902209123 | K884490 | 000 |