The following data is part of a premarket notification filed by Cook Incorporated with the FDA for White Sizing Catheter, Aurous Centimeter Sizing Catheter, Cava Vessel Sizing Catheter.
| Device ID | K162448 |
| 510k Number | K162448 |
| Device Name: | White Sizing Catheter, Aurous Centimeter Sizing Catheter, Cava Vessel Sizing Catheter |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | Cook Incorporated 750 Daniels Way Bloomington, IN 47402 |
| Contact | Jessica Swafford |
| Correspondent | Jessica Swafford Cook Incorporated 750 Daniels Way Bloomington, IN 47402 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-01 |
| Decision Date | 2017-05-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10827002473093 | K162448 | 000 |
| 10827002472997 | K162448 | 000 |
| 10827002473086 | K162448 | 000 |
| 10827002472980 | K162448 | 000 |