The following data is part of a premarket notification filed by Visitec Co. with the FDA for Visitec Needle Range (cardiovascular).
| Device ID | K811964 |
| 510k Number | K811964 |
| Device Name: | VISITEC NEEDLE RANGE (CARDIOVASCULAR) |
| Classification | Trocar |
| Applicant | VISITEC CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DRC |
| CFR Regulation Number | 870.1390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-07-10 |
| Decision Date | 1981-07-20 |