The following data is part of a premarket notification filed by Arrow Intl., Inc. with the FDA for Arrow-trerotola Percutaneous Thrombolytic Device Or Ptd, Models Pt-45509 (catheter Kit With Introducer Sheaths),pt-65.
| Device ID | K990829 |
| 510k Number | K990829 |
| Device Name: | ARROW-TREROTOLA PERCUTANEOUS THROMBOLYTIC DEVICE OR PTD, MODELS PT-45509 (CATHETER KIT WITH INTRODUCER SHEATHS),PT-65 |
| Classification | Catheter, Peripheral, Atherectomy |
| 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 | MCW |
| CFR Regulation Number | 870.4875 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-12 |
| Decision Date | 1999-05-04 |
| Summary: | summary |