The following data is part of a premarket notification filed by Gesco Intl., Inc. with the FDA for Thora-cath.
| Device ID | K941232 | 
| 510k Number | K941232 | 
| Device Name: | THORA-CATH | 
| Classification | Catheter And Tip, Suction | 
| Applicant | GESCO INTL., INC. 5714 EPSILON DR. San Antonio, TX 78249 | 
| Contact | Clyde N Baker | 
| Correspondent | Clyde N Baker GESCO INTL., INC. 5714 EPSILON DR. San Antonio, TX 78249 | 
| Product Code | JOL | 
| CFR Regulation Number | 880.6740 [🔎] | 
| Decision | Substantially Equivalent (SESE) | 
| Type | Traditional | 
| 3rd Party Reviewed | No | 
| Combination Product | No | 
| Date Received | 1994-03-15 | 
| Decision Date | 1994-05-11 | 
| Device Identifier | submissionNumber | Supplement | 
|---|---|---|
| H67141496091 | K941232 | 000 | 
| H67141414091 | K941232 | 000 | 
| H67141412091 | K941232 | 000 | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  THORA-CATH  76016454  2495841 Live/Registered | Utah Medical Products, Inc. 2000-04-03 | 
|  THORA-CATH  75492728  not registered Dead/Abandoned | C. R. Bard, Inc. 1998-05-29 |