Injector Handle with Syringe
FDA 510(k) K880987 · Applied Vascular Devices, Inc.
510(k) numberK880987
Submission
- Device name
- Injector Handle with Syringe
- Applicant
- Applied Vascular Devices, Inc.
Santa Ana, CA, US - Received
- March 8, 1988
- Decision date
- May 13, 1988
- 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 |
|---|---|---|
| K911730 | Surgical Obturator with SealGCJ · Traditional | 12/23/1991SE |
| K911589 | Disposable Surgical Trocar with SealGCJ · Traditional | 07/05/1991SE |
| K910339 | Avd Intimax Occlusion CatheterDQT · Traditional | 05/29/1991SE |
| K910372 | Intimax Thrombectomy CatheterDXE · Traditional | 04/26/1991SE |
| K911181 | Intimax(Tm) Irrigation CatheterGCA · Traditional | 04/18/1991SE |
| K910493 | Avd Intimax Cholangiography CatheterFGE · Traditional | 03/28/1991SE |
| K903848 | Diagnostic Intrascular CatheterDQO · Traditional | 03/25/1991SE |
| K905738 | Operative Cholangiographic CatheterFGE · Traditional | 03/21/1991SE |
| K910079 | Disposable Introducer SheathKDC · Traditional | 02/27/1991SE |
| K902256 | Irrigation Catheter 4, 6 and 10 FrenchDQY · Traditional | 02/15/1991SE |
Questions and answers
When was Injector Handle with Syringe cleared by the FDA?
Injector Handle with Syringe (K880987) received a 510(k) decision of Substantially Equivalent on May 13, 1988, 66 days after the submission was received.
What is the product code of K880987?
The FDA product code is DXT – Injector And Syringe, Angiographic, a Class II (moderate risk) device regulated under 21 CFR 870.1650.