Softrac-Pta Peripheral Dilatation Catheter
FDA 510(k) K882826 · Schneider-Shilley (Usa)
510(k) numberK882826
Submission
- Device name
- Softrac-Pta Peripheral Dilatation Catheter
- Applicant
- Schneider-Shilley (Usa)
Minneapolis, MN, US - Received
- July 8, 1988
- Decision date
- January 24, 1989
- 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 |
|---|---|---|
| K875175 | Modified Peripheral Dilatation CathetersLIT · Traditional | 07/28/1988SE |
| K881197 | Softrac-Pta(Tm) Peripheral Dilatation CatheterLIT · Traditional | 05/16/1988SE |
| K875323 | Modified Schneider-Shiley Wire TorquerDQX · Traditional | 03/28/1988SE |
| K875322 | Modified Schneider-Shiley Pressure ManometerKRK · Traditional | 03/28/1988SE |
| K875327 | Modified Seldinger Initial Puncture InstrumentDRE · Traditional | 03/25/1988SE |
| K875324 | Modified Schneider Shiley Inflation SyringesDXT · Traditional | 03/25/1988SE |
| K875326 | Modified Schneider-Shiley Flushing CatheterDQO · Traditional | 02/18/1988SE |
| K875325 | Modified Occluder/Flushing Catheter StopcockDQO · Traditional | 02/18/1988SE |
Questions and answers
When was Softrac-Pta Peripheral Dilatation Catheter cleared by the FDA?
Softrac-Pta Peripheral Dilatation Catheter (K882826) received a 510(k) decision of Substantially Equivalent on January 24, 1989, 200 days after the submission was received.
What is the product code of K882826?
The FDA product code is LIT – Catheter, Angioplasty, Peripheral, Transluminal, a Class II (moderate risk) device regulated under 21 CFR 870.1250.