The following data is part of a premarket notification filed by Critikon Company,llc with the FDA for Optically Clear Radiopaque Catheter.
| Device ID | K893546 |
| 510k Number | K893546 |
| Device Name: | OPTICALLY CLEAR RADIOPAQUE CATHETER |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | CRITIKON COMPANY,LLC 4110 GEORGE RD. P.O. BOX 31800 Tampa, FL 33631 -3800 |
| Contact | Raymond E Ursick |
| Correspondent | Raymond E Ursick CRITIKON COMPANY,LLC 4110 GEORGE RD. P.O. BOX 31800 Tampa, FL 33631 -3800 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-05-11 |
| Decision Date | 1989-11-01 |