PCA-10, 10CC Disp. Angiography Control Syringe
FDA 510(k) K890292 · Coeur Laboratories, Inc.
510(k) numberK890292
Submission
- Device name
- PCA-10, 10CC Disp. Angiography Control Syringe
- Applicant
- Coeur Laboratories, Inc.
Raleigh, NC, US - Received
- January 19, 1989
- Decision date
- June 22, 1989
- 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 |
|---|---|---|
| K971712 | Coeur 130 ML Angiographic SyringeDXT · Traditional | 10/08/1997SE |
| K965214 | Coeur Front Load Injector Retrofit Kit (C859-0002)DTX · Traditional | 03/28/1997SE |
| K960965 | Front Load Injector Turret Model 859-0001/200 ML Front Load Syringe Model 853-0211DXT · Traditional | 09/12/1996SE |
| K885138 | Capillary Tube, Blood CollectionGIO · Traditional | 02/07/1989SE |
| K885202 | 16 Long Catheter W/Adapter, 14 FR and 12 FRKOD · Traditional | 01/31/1989SE |
| K881646 | Urological CatheterKOD · Traditional | 06/16/1988SE |
| K874579 | Coeur Control SyringeFMF · Traditional | 01/19/1988SE |
| K873597 | Tubing, PolyethyleneDXT · Traditional | 11/12/1987SE |
| K823920 | Coeurlock Sterile Dispos. AngiographicDXT · Traditional | 02/18/1983SE |
Questions and answers
When was PCA-10, 10CC Disp. Angiography Control Syringe cleared by the FDA?
PCA-10, 10CC Disp. Angiography Control Syringe (K890292) received a 510(k) decision of Substantially Equivalent on June 22, 1989, 154 days after the submission was received.
What is the product code of K890292?
The FDA product code is DXT – Injector And Syringe, Angiographic, a Class II (moderate risk) device regulated under 21 CFR 870.1650.