The following data is part of a premarket notification filed by Angiodynamics, Inc. with the FDA for Mini Stick Envi Non-vascular Introducer Kit.
| Device ID | K170775 |
| 510k Number | K170775 |
| Device Name: | Mini Stick ENVI Non-Vascular Introducer Kit |
| Classification | Introducer, Catheter |
| Applicant | AngioDynamics, Inc. 26 Forest Street Marlborough, MA 01752 |
| Contact | Hans Kjolhede |
| Correspondent | Hans Kjolhede AngioDynamics, Inc. 26 Forest Street Marlborough, MA 01752 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-14 |
| Decision Date | 2017-07-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H965481040 | K170775 | 000 |
| H965355110 | K170775 | 000 |
| H965355100 | K170775 | 000 |
| H965355090 | K170775 | 000 |
| H965355080 | K170775 | 000 |
| H965355070 | K170775 | 000 |
| H965355060 | K170775 | 000 |
| H965355050 | K170775 | 000 |
| H965355040 | K170775 | 000 |
| H965355030 | K170775 | 000 |
| H965355020 | K170775 | 000 |
| H965355010 | K170775 | 000 |
| H965355120 | K170775 | 000 |
| H965355130 | K170775 | 000 |
| H965481031 | K170775 | 000 |
| H965481020 | K170775 | 000 |
| H965481010 | K170775 | 000 |
| H965481000 | K170775 | 000 |
| H965355200 | K170775 | 000 |
| H965355190 | K170775 | 000 |
| H965355180 | K170775 | 000 |
| H965355170 | K170775 | 000 |
| H965355160 | K170775 | 000 |
| H965355150 | K170775 | 000 |
| H965355140 | K170775 | 000 |
| H965481080 | K170775 | 000 |