The following data is part of a premarket notification filed by Implantable Devices with the FDA for Smithwick Carotid Shunt.
| Device ID | K021608 |
| 510k Number | K021608 |
| Device Name: | SMITHWICK CAROTID SHUNT |
| Classification | Clamp, Vascular |
| Applicant | IMPLANTABLE DEVICES P.O. BOX 270882 Tampa, FL 33688 |
| Contact | William E Mcpherson |
| Correspondent | William E Mcpherson IMPLANTABLE DEVICES P.O. BOX 270882 Tampa, FL 33688 |
| Product Code | DXC |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-05-16 |
| Decision Date | 2002-10-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858764006185 | K021608 | 000 |
| 00858764006017 | K021608 | 000 |
| 00858764006024 | K021608 | 000 |
| 00858764006031 | K021608 | 000 |
| 00858764006048 | K021608 | 000 |
| 00858764006055 | K021608 | 000 |
| 00858764006062 | K021608 | 000 |
| 00858764006093 | K021608 | 000 |
| 00858764006109 | K021608 | 000 |
| 00858764006116 | K021608 | 000 |
| 00858764006123 | K021608 | 000 |
| 00858764006130 | K021608 | 000 |
| 00858764006147 | K021608 | 000 |
| 00858764006154 | K021608 | 000 |
| 00858764006161 | K021608 | 000 |
| 00858764006178 | K021608 | 000 |
| 00858764006000 | K021608 | 000 |