Advance 418(TM)
FDA 510(k) K904984 · Peripheral Systems Group
510(k) numberK904984
Submission
- Device name
- Advance 418(TM)
- Applicant
- Peripheral Systems Group
Mountain View, CA, US - Received
- November 2, 1990
- Decision date
- April 12, 1991
- 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
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 |
|---|---|---|
| K940804 | Smartneedle Vascular Access System, ModificationITX · Traditional | 06/10/1994SE |
| K934433 | Vantage Dialtaion CatheterLIT · Traditional | 12/09/1993SE |
| K932777 | Smartneedle(R) Over-The-Needle CatheterITX · Traditional | 10/07/1993SE |
| K931327 | PSG Directional Hydrophilic Guide WireDQX · Traditional | 07/14/1993SE |
| K915554 | Hi-Torque Sport-T(Tm) Guide WireDQX · Traditional | 02/09/1993SE |
| K914979 | Edm(R) Infusion CatheterKRA · Traditional | 09/16/1992SE |
| K913941 | Psg(Tm) 20 Guage Doppler NeedleITX · Traditional | 02/27/1992SE |
| K915168 | Proflex 5LIT · Traditional | 02/19/1992SE |
| K913477 | Apex(Tm) Prostatic Balloon Dilation CatheterKOE · Traditional | 12/27/1991SE |
| K913746 | Smartneedle(Tm) Vascular Access SystemITX · Traditional | 12/17/1991SE |
Questions and answers
When was Advance 418(TM) cleared by the FDA?
Advance 418(TM) (K904984) received a 510(k) decision of Substantially Equivalent on April 12, 1991, 161 days after the submission was received.
What is the product code of K904984?
The FDA product code is LIT – Catheter, Angioplasty, Peripheral, Transluminal, a Class II (moderate risk) device regulated under 21 CFR 870.1250.