The following data is part of a premarket notification filed by Gesco Intl., Inc. with the FDA for Gesco Per-q-cath Needle.
| Device ID | K911215 |
| 510k Number | K911215 |
| Device Name: | GESCO PER-Q-CATH NEEDLE |
| Classification | Catheter, Angioplasty, Peripheral, Transluminal |
| 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 | LIT |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-19 |
| Decision Date | 1991-06-06 |