Simpson Peripheral Atherocath W/Addit. Size 13F
FDA 510(k) K883346 · Devices For Vascular Intervention, Inc.
510(k) numberK883346
Submission
- Device name
- Simpson Peripheral Atherocath W/Addit. Size 13F
- Applicant
- Devices For Vascular Intervention, Inc.
Redwood City, CA, US - Received
- July 28, 1988
- Decision date
- September 26, 1988
- 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
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| 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 |
|---|---|---|
| K935929 | MicrotrackMCW · Traditional | 03/10/1994SE |
| K920707 | Hollow Motor Drive Unit W/ Torque ControllerMCW · Traditional | 11/23/1992SE |
| K914422 | Devices for Vascu Intervent Rotat Hemostat ValveDQY · Traditional | 12/18/1991SE |
| K911678 | Rotating Hemostatic ValveDYB · Traditional | 07/12/1991SE |
| K910205 | LP-60 Low Pressure Inflation DeviceMAV · Traditional | 02/25/1991SE |
| K901601 | Hollow Motor Drive UnitLIT · Traditional | 07/06/1990SE |
| K883933 | Introducing CatheterDYB · Traditional | 12/02/1988SE |
| K883981 | Guiding Catheter (Tip Softness Change)DWF · Traditional | 11/03/1988SE |
| K883916 | Rotating Hemostatic ValveDQY · Traditional | 10/28/1988SE |
| K881088 | Addition of a Tip Guard to the Atherocath(Tm)LIT · Traditional | 05/31/1988SE |
Questions and answers
When was Simpson Peripheral Atherocath W/Addit. Size 13F cleared by the FDA?
Simpson Peripheral Atherocath W/Addit. Size 13F (K883346) received a 510(k) decision of Substantially Equivalent on September 26, 1988, 60 days after the submission was received.
What is the product code of K883346?
The FDA product code is LIT – Catheter, Angioplasty, Peripheral, Transluminal, a Class II (moderate risk) device regulated under 21 CFR 870.1250.