The following data is part of a premarket notification filed by Applied Vascular Devices, Inc. with the FDA for Intimax Thrombectomy Catheter.
| Device ID | K910372 |
| 510k Number | K910372 |
| Device Name: | INTIMAX THROMBECTOMY CATHETER |
| Classification | Catheter, Embolectomy |
| Applicant | APPLIED VASCULAR DEVICES, INC. 26051 MERIT CIRCLE, #104 Laguna Hills, CA 92653 |
| Contact | Jo Stegwell |
| Correspondent | Jo Stegwell APPLIED VASCULAR DEVICES, INC. 26051 MERIT CIRCLE, #104 Laguna Hills, CA 92653 |
| Product Code | DXE |
| CFR Regulation Number | 870.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-01-29 |
| Decision Date | 1991-04-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840663109852 | K910372 | 000 |
| 00840663109845 | K910372 | 000 |
| 00840663109838 | K910372 | 000 |
| 00840663109821 | K910372 | 000 |
| 00840663109814 | K910372 | 000 |
| 00840663109807 | K910372 | 000 |
| 00840663109784 | K910372 | 000 |