Schneider-Shiley Biflator Balloon Inflation Device
FDA 510(k) K872472 · Angiomedics, Inc.
510(k) numberK872472
Submission
- Device name
- Schneider-Shiley Biflator Balloon Inflation Device
- Applicant
- Angiomedics, Inc.
Minneapolis, MN, US - Received
- June 23, 1987
- Decision date
- September 14, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DXT – Injector And Syringe, Angiographic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1650
- Specialty
- Cardiovascular
Other 510(k)s with product code DXT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252652 | Disposable Syringes with Accessories for Power Injectors (900103T); Disposable Syringes…DXT · Traditional | Fortis Biosolutions Company Limited | 05/14/2026SE |
| K252653 | ACIST Pro Diagnostic System (019304); Processing Unit Bed Mount; AngioTouch Module…DXT · Traditional | Acist Medical Systems, Inc. | 05/13/2026SE |
| K252638 | VeraPro S100 Multi-Use Syringe (018808); VeraPro S100 LV1 Low Viscosity Single-Use…DXT · Traditional | Acist Medical Systems, Inc. | 05/13/2026SE |
| K253048 | High Pressure Syringe; Pressure Connecting Tube; Quick fill tube; Spike; Transfer TubeDXT · Traditional | Shenzhen Maiwei Biotech Co., Ltd. | 04/16/2026SE |
| K251788 | Extension tubeDXT · Traditional | Zhuhai DR Medical Instruments Co., Ltd. | 03/05/2026SE |
| K252891 | MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD ISI2…DXT · Traditional | Bayer Medical Care, Inc. | 02/13/2026SE |
| K244038 | High Pressure TubingDXT · Traditional | Shandong Int Medical Instruments Co., Ltd. | 09/05/2025SE |
| K242143 | Angiography InjectorDXT · Traditional | Shandong Int Medical Instruments Co., Ltd. | 12/23/2024SE |
| K242212 | Disposable Syringe (Kit); Nemoto Disposable Syringe (Kit)DXT · Traditional | Nemoto Kyorindo Co., Ltd. | 08/27/2024SE |
| K241109 | Single-use Sterile High-pressure Angiographic Syringes and AccessoriesDXT · Traditional | Shenzhen Boon Medical Supply Co., Ltd. | 08/22/2024SE |
More from Shenzhen Boon Medical Supply Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K873195 | Schneider-Shiley Angioport(Tm) Ptca Intro W/HemoDYB · Traditional | 12/15/1987SE |
| K872542 | Schneider-Shiley Softrac-Pta(Tm) Angio. CatheterLIT · 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 Biflator Balloon Inflation Device cleared by the FDA?
Schneider-Shiley Biflator Balloon Inflation Device (K872472) received a 510(k) decision of Substantially Equivalent on September 14, 1987, 83 days after the submission was received.
What is the product code of K872472?
The FDA product code is DXT – Injector And Syringe, Angiographic, a Class II (moderate risk) device regulated under 21 CFR 870.1650.