The following data is part of a premarket notification filed by Interview Medical Technology Corp. with the FDA for Vyker Silicone Epistaxis Catheter V-27030, Vyker Silicone Epistaxis Catheter Kit V-2703k.
| Device ID | K972922 |
| 510k Number | K972922 |
| Device Name: | VYKER SILICONE EPISTAXIS CATHETER V-27030, VYKER SILICONE EPISTAXIS CATHETER KIT V-2703K |
| Classification | Balloon, Epistaxis |
| Applicant | INTERVIEW MEDICAL TECHNOLOGY CORP. 3941 PARK DR., SUITE 20-325 El Dorado Hills, CA 95762 |
| Contact | Lou Matson |
| Correspondent | Lou Matson INTERVIEW MEDICAL TECHNOLOGY CORP. 3941 PARK DR., SUITE 20-325 El Dorado Hills, CA 95762 |
| Product Code | EMX |
| CFR Regulation Number | 874.4100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-08-08 |
| Decision Date | 1997-10-08 |