Van-Tec C-Flex Suprapubic Balloon Catheter Set
FDA 510(k) K870556 · Van-Tec, Inc.
510(k) numberK870556
Submission
- Device name
- Van-Tec C-Flex Suprapubic Balloon Catheter Set
- Applicant
- Van-Tec, Inc.
Spencer, IN, US - Received
- February 10, 1987
- Decision date
- March 10, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KOB – Catheter, Suprapubic (And Accessories)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5090
- Specialty
- Gastroenterology, Urology
- Implant
- Yes
Other 510(k)s with product code KOB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K240514 | AMT Low-Profile Suprapubic Catheter & Drainage SetKOB · Traditional | Applied Medical Technology, Inc. | 11/01/2024SE |
| K181097 | Cook Cystostomy Catheter SetKOB · Traditional | Cook Incorporated | 01/18/2019SESK |
| K182709 | One-Step Suprapubic IntroducerKOB · Traditional | Cook Incorporated | 12/26/2018SE |
| K182066 | O'Brien Suprapubic Introducer Set, Cook SP Tube Introducer SetKOB · Traditional | Cook Incorporated | 10/30/2018SESK |
| K132890 | Suprapubic Catheter and Introducer SetKOB · Traditional | Mediplus , Ltd. | 01/17/2014SE |
| K120127 | Swan Valley Medical Tranurethral Suprapubic Endo-Cystostomy (T-Spec) Surgical SystemKOB · Traditional | Swan Valley Medical, Incorporated | 10/26/2012SE |
| K014002 | All Silicone Supra-Pubia Catheter, Models 4880/4890KOB · Traditional | Fortune Medical Instrument Corp. | 03/04/2002SE |
| K012153 | Lowsley Suprapubic TractorKOB · Traditional | Circon Video | 09/19/2001SE |
| K970969 | Kendall Curity Suprapubic Catheter Tray, Kit, & Replacement SetKOB · Traditional | The Kendal Co. | 04/23/1997SE |
| K970021 | Rusch Suprapubic TrayKOB · Traditional | Rusch, Inc. | 02/07/1997SE |
More from Rusch, 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 Van-Tec C-Flex Suprapubic Balloon Catheter Set cleared by the FDA?
Van-Tec C-Flex Suprapubic Balloon Catheter Set (K870556) received a 510(k) decision of Substantially Equivalent on March 10, 1987, 28 days after the submission was received.
What is the product code of K870556?
The FDA product code is KOB – Catheter, Suprapubic (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 876.5090.