Schneider-Shiley Softrac-Pta(Tm) Angio. Catheter
FDA 510(k) K872542 · Angiomedics, Inc.
510(k) numberK872542
Submission
- Device name
- Schneider-Shiley Softrac-Pta(Tm) Angio. Catheter
- Applicant
- Angiomedics, Inc.
Minneapolis, MN, US - Received
- June 29, 1987
- Decision date
- September 14, 1987
- 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 |
|---|---|---|
| K873195 | Schneider-Shiley Angioport(Tm) Ptca Intro W/HemoDYB · Traditional | 12/15/1987SE |
| K872472 | Schneider-Shiley Biflator Balloon Inflation DeviceDXT · Traditional | 09/14/1987SE |
| K863342 | Softip Coronary Sinus Cardioplegia CatheterDWF · Traditional | 03/03/1987SE |
| K861238 | Angiomedics Cath Sheath Introduc W/Hemostasis ValvDYB · Traditional | 07/16/1986SE |
| K852872 | Angiomedics Softip CatheterDQO · Traditional | 10/11/1985SE |
| K850271 | Angiomedic's Catheter-Diagnostic IntravascularDQO · Traditional | 04/03/1985SE |
| K834275 | Softip CatheterDQO · Traditional | 02/04/1984SE |
Questions and answers
When was Schneider-Shiley Softrac-Pta(Tm) Angio. Catheter cleared by the FDA?
Schneider-Shiley Softrac-Pta(Tm) Angio. Catheter (K872542) received a 510(k) decision of Substantially Equivalent on September 14, 1987, 77 days after the submission was received.
What is the product code of K872542?
The FDA product code is LIT – Catheter, Angioplasty, Peripheral, Transluminal, a Class II (moderate risk) device regulated under 21 CFR 870.1250.