Scimed Viper Catheter
FDA 510(k) K915347 · Scimed
510(k) numberK915347
Submission
- Device name
- Scimed Viper Catheter
- Applicant
- Scimed
Maple Grove, MN, US - Received
- November 26, 1991
- Decision date
- August 17, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
|---|---|---|
| K992142 | Scimed Angiographic CathetersDQO · Special | 07/21/1999SE |
| K953909 | Scimed 6 French Micro-Max Guide CatheterDQY · Traditional | 11/13/1995SE |
| K931584 | Scimed Transport Steerable Guide Wire and Access.DQX · Traditional | 07/01/1993SE |
| K922706 | Scimed SidelinerDQX · Traditional | 12/10/1992SE |
| K910987 | 7FR. and 8FR. Triguide Guiding Catheter Add. CurveDQO · Traditional | 05/29/1991SE |
| K904171 | Scimed Cardiotherm Cardioplegia Delivery SystemDTR · Traditional | 12/06/1990SE |
| K903503 | Scimed Encore Inflation Device, Model SM2500MAV · Traditional | 10/09/1990SE |
Questions and answers
When was Scimed Viper Catheter cleared by the FDA?
Scimed Viper Catheter (K915347) received a 510(k) decision of Substantially Equivalent on August 17, 1992, 265 days after the submission was received.
What is the product code of K915347?
The FDA product code is LIT – Catheter, Angioplasty, Peripheral, Transluminal, a Class II (moderate risk) device regulated under 21 CFR 870.1250.