The following data is part of a premarket notification filed by Angiodynamics, Inc. with the FDA for Soft-vu, Mariner, Accu-vu And Angiooptic Catheters.
| Device ID | K161596 |
| 510k Number | K161596 |
| Device Name: | Soft-Vu, Mariner, Accu-Vu And AngioOptic Catheters |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | AngioDynamics, Inc. 603 Queensbury Ave Queensbury, NY 12804 |
| Contact | Teri Juckett |
| Correspondent | Teri Juckett AngioDynamics, Inc. 603 Queensbury Ave Queensbury, NY 12804 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-09 |
| Decision Date | 2017-04-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H787107100050 | K161596 | 000 |
| H787107100340 | K161596 | 000 |
| H787107100350 | K161596 | 000 |
| H787107100370 | K161596 | 000 |
| H787107100380 | K161596 | 000 |
| H787107100390 | K161596 | 000 |
| H787107100400 | K161596 | 000 |
| H787107100410 | K161596 | 000 |
| H787107100430 | K161596 | 000 |
| H787107100160 | K161596 | 000 |
| H787107100150 | K161596 | 000 |
| H787107100070 | K161596 | 000 |
| H787107100080 | K161596 | 000 |
| H787107100090 | K161596 | 000 |
| H787107100100 | K161596 | 000 |
| H787107100110 | K161596 | 000 |
| H787107100120 | K161596 | 000 |
| H787107100130 | K161596 | 000 |
| H787107100140 | K161596 | 000 |
| H787107100620 | K161596 | 000 |
| H787107229910 | K161596 | 000 |
| H787117092350 | K161596 | 000 |
| H787117092370 | K161596 | 000 |
| H787117092380 | K161596 | 000 |
| H787117092400 | K161596 | 000 |
| H787117092430 | K161596 | 000 |
| H787117227110 | K161596 | 000 |
| H787117227120 | K161596 | 000 |
| H787137099200 | K161596 | 000 |
| H787117092300 | K161596 | 000 |
| H787117092290 | K161596 | 000 |
| H787117092050 | K161596 | 000 |
| H787117092170 | K161596 | 000 |
| H787117092190 | K161596 | 000 |
| H787117092230 | K161596 | 000 |
| H787117092240 | K161596 | 000 |
| H787117092250 | K161596 | 000 |
| H787117092260 | K161596 | 000 |
| H787117092280 | K161596 | 000 |
| H787107100060 | K161596 | 000 |