The following data is part of a premarket notification filed by Arrow Intl., Inc. with the FDA for Stainless Steel Gen Pur Interventional Guide Wires.
| Device ID | K914531 |
| 510k Number | K914531 |
| Device Name: | STAINLESS STEEL GEN PUR INTERVENTIONAL GUIDE WIRES |
| 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 | 1991-10-11 |
| Decision Date | 1992-02-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30801902101540 | K914531 | 000 |
| 40801902122542 | K914531 | 000 |
| 30801902007330 | K914531 | 000 |
| 40801902122467 | K914531 | 000 |
| 40801902122474 | K914531 | 000 |
| 40801902122498 | K914531 | 000 |
| 30801902122538 | K914531 | 000 |
| 40801902128902 | K914531 | 000 |
| 30801902003288 | K914531 | 000 |
| 30801902003295 | K914531 | 000 |
| 20801902003304 | K914531 | 000 |
| 40801902122450 | K914531 | 000 |
| 30801902003226 | K914531 | 000 |
| 30801902003264 | K914531 | 000 |
| 30801902007316 | K914531 | 000 |
| 20801902218968 | K914531 | 000 |