Deflecting Guide Wire
FDA 510(k) K833242 · Van-Tec, Inc.
510(k) numberK833242
Submission
- Device name
- Deflecting Guide Wire
- Applicant
- Van-Tec, Inc.
Mchenry, IL, US - Received
- August 18, 1983
- Decision date
- October 19, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KNY – Accessories, Catheter, G-U
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5130
- Specialty
- Gastroenterology, Urology
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| K141252 | Guardian Urethral SheathKNY · Special | Solace Therapeutics | 06/09/2014SE |
| K131803 | Guardian Urethral SheathKNY · Special | Solace Therapeutics | 08/20/2013SE |
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More from Avail Medical Products, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K880099 | Van-Tec Bladder EvacuatorKQT · Traditional | 03/02/1988SE |
| K880098 | Van-Tec Auto Biopsy NeedleKNW · Traditional | 03/02/1988SE |
| K880096 | Van-Tec Aspiration Biopsy System W/Collection CupKNW · Traditional | 03/02/1988SE |
| K880095 | Berger Prostate Culture Cytology BrushFDX · Traditional | 03/02/1988SE |
| K880094 | Van-Tec Endopyelotomy KnifeEMF · Traditional | 02/29/1988SE |
| K874112 | Van-Tec Double Occlusion Balloon CatheterKOD · Traditional | 02/11/1988SE |
| K871779 | Helical Stone Basket (Disposable)FFL · Traditional | 06/17/1987SE |
| K871777 | Van-Tec Reusable Helical Stone BasketFFL · Traditional | 06/17/1987SE |
| K870696 | Van-Tec Segura Stone Basket W/Protective SheathFFL · Traditional | 03/30/1987SE |
| K870679 | Van-Tec Modular Flexible CystourethroscopeFBO · Traditional | 03/30/1987SE |
Questions and answers
When was Deflecting Guide Wire cleared by the FDA?
Deflecting Guide Wire (K833242) received a 510(k) decision of Substantially Equivalent on October 19, 1983, 62 days after the submission was received.
What is the product code of K833242?
The FDA product code is KNY – Accessories, Catheter, G-U, a Class II (moderate risk) device regulated under 21 CFR 876.5130.