The following data is part of a premarket notification filed by Universal Medical Instrument Corp. with the FDA for Pet Polyethylene Torque Catheter.
| Device ID | K812999 |
| 510k Number | K812999 |
| Device Name: | PET POLYETHYLENE TORQUE CATHETER |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | UNIVERSAL MEDICAL INSTRUMENT CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-10-26 |
| Decision Date | 1981-11-16 |