The following data is part of a premarket notification filed by Highpoint Medical Corp. with the FDA for Cath Control.
| Device ID | K914211 |
| 510k Number | K914211 |
| Device Name: | CATH CONTROL |
| Classification | Accessories, Catheter, G-u |
| Applicant | HIGHPOINT MEDICAL CORP. P.O. BOX 170873 Arlington, TX 76003 |
| Contact | Roger Liebelt |
| Correspondent | Roger Liebelt HIGHPOINT MEDICAL CORP. P.O. BOX 170873 Arlington, TX 76003 |
| Product Code | KNY |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-09-19 |
| Decision Date | 1991-11-22 |