The following data is part of a premarket notification filed by Arrow Intl., Inc. with the FDA for Arrow Multipolar Intracardiac Electrode Catheters.
| Device ID | K945229 |
| 510k Number | K945229 |
| Device Name: | ARROW MULTIPOLAR INTRACARDIAC ELECTRODE CATHETERS |
| 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 | 1994-10-26 |
| Decision Date | 1995-08-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30801902085284 | K945229 | 000 |
| 20801902198390 | K945229 | 000 |
| 20801902198406 | K945229 | 000 |
| 20801902198307 | K945229 | 000 |
| 20801902211501 | K945229 | 000 |
| 20801902211488 | K945229 | 000 |
| 20801902198314 | K945229 | 000 |
| 30801902198250 | K945229 | 000 |
| 20801902198345 | K945229 | 000 |
| 20801902004530 | K945229 | 000 |
| 00801902004512 | K945229 | 000 |
| 40801902004541 | K945229 | 000 |
| 30801902004537 | K945229 | 000 |
| 40801902004510 | K945229 | 000 |
| 60801902004316 | K945229 | 000 |
| 30801902004308 | K945229 | 000 |
| 60801902004248 | K945229 | 000 |
| 10801902004304 | K945229 | 000 |
| 00801902004543 | K945229 | 000 |
| 20801902198376 | K945229 | 000 |