The following data is part of a premarket notification filed by Arrow Intl., Inc. with the FDA for Diagnostic Electrophysiology Catheter System.
| Device ID | K953651 |
| 510k Number | K953651 |
| Device Name: | DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER SYSTEM |
| Classification | Catheter, Electrode Recording, Or Probe, Electrode Recording |
| Applicant | ARROW INTL., INC. 3000 BERNVILLE RD. Reading, PA 19605 |
| Contact | Thomas D Nickel |
| Correspondent | Thomas D Nickel ARROW INTL., INC. 3000 BERNVILLE RD. Reading, PA 19605 |
| Product Code | DRF |
| CFR Regulation Number | 870.1220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-04 |
| Decision Date | 1995-11-30 |