Gesco Per-Q-Cath Needle
FDA 510(k) K911215 · Gesco Intl., Inc.
510(k) numberK911215
Submission
- Device name
- Gesco Per-Q-Cath Needle
- Applicant
- Gesco Intl., Inc.
San Antonio, TX, US - Received
- March 19, 1991
- Decision date
- June 6, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LIT – Catheter, Angioplasty, Peripheral, Transluminal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1250
- Specialty
- Cardiovascular
Other 510(k)s with product code LIT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260304 | WAVE PTA Balloon CatheterLIT · Traditional | WAVE Medical AG | 05/20/2026SE |
| K252512 | Armada 14 NC PTA CatheterLIT · Traditional | Abbott Medical | 02/13/2026SE |
| K251915 | Amethyst HP PTA OTW 0.035 CatheterLIT · Traditional | Natec Medical , Ltd. | 12/18/2025SE |
| K250706 | Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters…LIT · Special | Biotronik, Inc. | 04/04/2025SE |
| K243704 | Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon…LIT · Traditional | Brosmed Medical Co., Ltd. | 02/27/2025SE |
| K241040 | Amethyst HP PTA OTW 0.035 CatheterLIT · Traditional | Natec Medical , Ltd. | 12/18/2024SE |
| K242419 | 018 Hydrophilic Coated OTW PTA Balloon Dilatation CatheterLIT · Traditional | Creagh Medical Ltd. Dba Surmodics, Inc. | 11/15/2024SE |
| K241740 | Finesse Injectable PTA Balloon Dilatation CatheterLIT · Special | Summa Therapeutics | 07/16/2024SE |
| K241711 | Oscar Peripheral Multifunctional Catheter systemLIT · Special | Biotronik, Inc. | 07/11/2024SE |
| K241683 | Sterling MONORAIL PTA Balloon Dilatation Catheter (H74939031404020 ); Sterling…LIT · Special | Boston Scientific Corporation | 07/10/2024SE |
More from Boston Scientific Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K954422 | Per-Q-Cath Mid-LineLJS · Traditional | 12/15/1995SE |
| K940953 | Umbili-Cath-SFOS · Traditional | 08/02/1994SE |
| K940870 | Umbili-CathFOS · Traditional | 08/02/1994SE |
| K940952 | Umbili-Cath-S-DlFOS · Traditional | 07/29/1994SE |
| K941672 | Uri-Cath CatheterGBM · Traditional | 05/16/1994SE |
| K941232 | Thora-CathJOL · Traditional | 05/11/1994SE |
| K940871 | Umbili-Cath-PFOS · Traditional | 04/29/1994SE |
| K931989 | Ventri-CathJXG · Traditional | 07/21/1993SE |
| K926063 | Per-Q-Cath Dressing Change TrayMCY · Traditional | 06/07/1993SEKD |
| K923591 | Pala-NateBTR · Traditional | 03/16/1993SE |
Questions and answers
When was Gesco Per-Q-Cath Needle cleared by the FDA?
Gesco Per-Q-Cath Needle (K911215) received a 510(k) decision of Substantially Equivalent on June 6, 1991, 79 days after the submission was received.
What is the product code of K911215?
The FDA product code is LIT – Catheter, Angioplasty, Peripheral, Transluminal, a Class II (moderate risk) device regulated under 21 CFR 870.1250.