The following data is part of a premarket notification filed by Arrow Intl., Inc. with the FDA for Arrow Bipolar Pacing/balloon Wedge Pressure Catheter.
| Device ID | K960479 |
| 510k Number | K960479 |
| Device Name: | ARROW BIPOLAR PACING/BALLOON WEDGE PRESSURE CATHETER |
| Classification | Electrode, Pacemaker, Temporary |
| 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 | LDF |
| CFR Regulation Number | 870.3680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-02-02 |
| Decision Date | 1996-10-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 60801902004750 | K960479 | 000 |
| 20801902198383 | K960479 | 000 |
| 20801902216117 | K960479 | 000 |