The following data is part of a premarket notification filed by Cook Incorporated with the FDA for Lumax Guiding Catheter.
| Device ID | K191163 |
| 510k Number | K191163 |
| Device Name: | Lumax Guiding Catheter |
| Classification | Catheter, Percutaneous |
| Applicant | Cook Incorporated 750 Daniels Way Bloomington, IN 47404 |
| Contact | David Lehr |
| Correspondent | David Lehr Cook Incorporated 750 Daniels Way Bloomington, IN 47404 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-05-01 |
| Decision Date | 2019-12-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00827002476318 | K191163 | 000 |