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.
| Device ID | K011056 |
| 510k Number | K011056 |
| Device Name: | ARROW-TREROTOLA PERCUTANEOUS THROMBOLYTIC DEVICE OR PTD |
| 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 | 2001-04-06 |
| Decision Date | 2001-10-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10801902026207 | K011056 | 000 |
| 40801902121255 | K011056 | 000 |
| 40801902121286 | K011056 | 000 |
| 40801902121316 | K011056 | 000 |
| 20801902196617 | K011056 | 000 |
| 20801902194101 | K011056 | 000 |
| 20801902194095 | K011056 | 000 |
| 20801902194088 | K011056 | 000 |
| 20801902194071 | K011056 | 000 |
| 20801902194064 | K011056 | 000 |
| 20801902194057 | K011056 | 000 |
| 20801902194040 | K011056 | 000 |
| 40801902121262 | K011056 | 000 |
| 40801902121309 | K011056 | 000 |
| 10801902025316 | K011056 | 000 |
| 10801902025309 | K011056 | 000 |
| 10801902013177 | K011056 | 000 |
| 10801902013160 | K011056 | 000 |
| 10801902013153 | K011056 | 000 |
| 10801902013146 | K011056 | 000 |
| 10801902013108 | K011056 | 000 |
| 10801902013085 | K011056 | 000 |
| 40801902121293 | K011056 | 000 |
| 10801902156744 | K011056 | 000 |
| 10801902156751 | K011056 | 000 |
| 20801902196600 | K011056 | 000 |