The following data is part of a premarket notification filed by Arrow Intl., Inc. with the FDA for Arrow Quadpolar Mapping/pacing Catheter.
| Device ID | K911065 |
| 510k Number | K911065 |
| Device Name: | ARROW QUADPOLAR MAPPING/PACING CATHETER |
| Classification | Catheter, Electrode Recording, Or Probe, Electrode Recording |
| 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 | DRF |
| CFR Regulation Number | 870.1220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-13 |
| Decision Date | 1992-06-18 |