The following data is part of a premarket notification filed by Hudson Respiratory Care, Inc. with the FDA for Cath-guide.
| Device ID | K955645 |
| 510k Number | K955645 |
| Device Name: | CATH-GUIDE |
| Classification | Catheters, Suction, Tracheobronchial |
| Applicant | HUDSON RESPIRATORY CARE, INC. 6329 W. WATERVIEW CT. Mccordsville, IN 46055 -9501 |
| Contact | Paul E Dryden |
| Correspondent | Paul E Dryden HUDSON RESPIRATORY CARE, INC. 6329 W. WATERVIEW CT. Mccordsville, IN 46055 -9501 |
| Product Code | BSY |
| CFR Regulation Number | 868.6810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-12-12 |
| Decision Date | 1996-03-12 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() CATH-GUIDE 75513068 2272128 Live/Registered |
TELEFLEX MEDICAL INCORPORATED 1998-07-06 |
![]() CATH-GUIDE 72411492 0958994 Dead/Cancelled |
HUDSON OXYGEN THERAPY SALES COMPANY 1971-12-30 |