The following data is part of a premarket notification filed by Vascular Architects, Inc. with the FDA for Vascular Architects Periscope Device.
| Device ID | K003719 |
| 510k Number | K003719 |
| Device Name: | VASCULAR ARCHITECTS PERISCOPE DEVICE |
| Classification | Stripper, Artery, Intraluminal |
| Applicant | VASCULAR ARCHITECTS, INC. 1830 BERING DR. San Jose, CA 95112 -4226 |
| Contact | Jean M Caillouette |
| Correspondent | Jean M Caillouette VASCULAR ARCHITECTS, INC. 1830 BERING DR. San Jose, CA 95112 -4226 |
| Product Code | DWX |
| CFR Regulation Number | 870.4875 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-12-04 |
| Decision Date | 2001-02-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840663102570 | K003719 | 000 |
| 00840663102563 | K003719 | 000 |