The following data is part of a premarket notification filed by Gesco Intl., Inc. with the FDA for Gesco Per-q-cath Repair Kit.
| Device ID | K910622 |
| 510k Number | K910622 |
| Device Name: | GESCO PER-Q-CATH REPAIR KIT |
| Classification | Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
| Applicant | GESCO INTL., INC. 5714 EPSILON DR. San Antonio, TX 78249 |
| Contact | N Baker |
| Correspondent | N Baker GESCO INTL., INC. 5714 EPSILON DR. San Antonio, TX 78249 |
| Product Code | LJS |
| CFR Regulation Number | 880.5970 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-02-12 |
| Decision Date | 1991-03-29 |