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 |