Kadir Hi-Torque Guide Wire
FDA 510(k) K871297 · Argon Medical Corp.
510(k) numberK871297
Submission
- Device name
- Kadir Hi-Torque Guide Wire
- Applicant
- Argon Medical Corp.
Athens, TX, US - Received
- March 31, 1987
- Decision date
- April 10, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KOD – Catheter, Urological
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5130
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code KOD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251864 | Rubber Utility CatheterKOD · Traditional | C.R. Bard, Inc. | 02/23/2026SE |
| K220036 | Wellead Ureteral CatheterKOD · Traditional | Well Lead Medical Co., Ltd. | 12/16/2022SE |
| K220730 | allFlex Ureteral Catheters, Krait Ureteral CathetersKOD · Traditional | Allwin Medical Devices, Inc. | 10/13/2022SE |
| K211032 | Urinary Catheter 12 Fr, Urinary Catheter 16 FrKOD · Traditional | Urogen Pharma, Ltd. | 11/19/2021SE |
| K181979 | Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent CatheterKOD · Traditional | Teleflexmedical, Inc. | 05/24/2019SE |
| K180354 | UroGen Ureteral CatheterKOD · Traditional | Urogen Pharma, Ltd. | 10/30/2018SE |
| K181144 | Angled Tip Ureteral CatheterKOD · Traditional | Cook Incorporated | 06/28/2018SE |
| K180530 | Imager II Urology Torque CatheterKOD · Special | Boston Scientific Corporation | 04/10/2018SE |
| K171810 | Cone Tip Ureteral Catheter, Rutner Universal Wedge CatheterKOD · Traditional | Cook Incorporated | 03/07/2018SE |
| K171600 | Renal Access Cobra Catheter, Kumpe Access CatheterKOD · Traditional | Cook Incorporated | 02/16/2018SE |
More from Cook Incorporated
| 510(k) | Device | Decision |
|---|---|---|
| K130730 | V-Stick Vascular Access SetDYB · Special | 11/22/2013SE |
| K904994 | Closed System Flush SetDXT · Traditional | 01/15/1991SE |
| K895511 | Catheter Balloon Dilator Pressure GaugeMAV · Traditional | 02/28/1990SE |
| K894157 | ObturatorDYB · Traditional | 09/28/1989SE |
| K891022 | Introducer for Ptca Guiding CathetersDYB · Traditional | 05/19/1989SE |
| K884375 | Translumbar Aortography Needle CatheterDQR · Traditional | 01/11/1989SE |
| K882221 | Over the Needle Catheter, Arterial Catheter NeedleDYB · Traditional | 08/12/1988SE |
| K853312 | Argon Cut Biopsy Needles, Various SizesDWO · Traditional | 09/12/1985SE |
| K852880 | Peel-Away Sheath(A Component of Argon Introd Set)DYB · Traditional | 08/29/1985SE |
| K844555 | Pathfinder Cardiovascular CatheterDQO · Traditional | 03/27/1985SE |
Questions and answers
When was Kadir Hi-Torque Guide Wire cleared by the FDA?
Kadir Hi-Torque Guide Wire (K871297) received a 510(k) decision of Substantially Equivalent on April 10, 1987, 10 days after the submission was received.
What is the product code of K871297?
The FDA product code is KOD – Catheter, Urological, a Class II (moderate risk) device regulated under 21 CFR 876.5130.