The following data is part of a premarket notification filed by Arrow Intl., Inc. with the FDA for Arrow 5fx60cm Balloon Embolectomy Catheter, Model # Em-56025.
| Device ID | K982141 |
| 510k Number | K982141 |
| Device Name: | ARROW 5FX60CM BALLOON EMBOLECTOMY CATHETER, MODEL # EM-56025 |
| Classification | Catheter, Embolectomy |
| Applicant | ARROW INTL., INC. 2400 BERNVILLE RD. Reading, PA 19605 |
| Contact | Thomas D Nickel |
| Correspondent | Thomas D Nickel ARROW INTL., INC. 2400 BERNVILLE RD. Reading, PA 19605 |
| Product Code | DXE |
| CFR Regulation Number | 870.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-06-17 |
| Decision Date | 1998-08-31 |
| Summary: | summary |