Medrad Mark 7 Arterion (Pedestal System / Table Mount System), Medrad Mark 7 Arterion Syringe
FDA 510(k) K112086 · Medrad, Inc.
510(k) numberK112086
Submission
- Device name
- Medrad Mark 7 Arterion (Pedestal System / Table Mount System), Medrad Mark 7 Arterion Syringe
- Applicant
- Medrad, Inc.
Indianola, PA, US - Received
- July 21, 2011
- Decision date
- October 14, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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
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|---|---|---|---|
| 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 |
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| K130381 | Angiojet Ultra Power Pulse KitQEW · Traditional | 07/29/2013SE |
| K130637 | Jetstream XC 2.4/3.4 System; Jetstream XC 2.1/3.0 System; Jetstream SC 1.85 System…MCW · Special | 04/10/2013SE |
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| K113363 | Angiojet Solent Dista Thrombectomy SetQEZ · Traditional | 06/06/2012SE |
| K113133 | Medrad Mark 7 Arterion (Pedestal System), (Table Mount System), Medrad Mark 7 Arterion…DXT · Special | 12/15/2011SE |
| K113428 | Angiojet Ultra DVX Thrombectomy SetQEZ · Special | 12/02/2011SE |
| K111182 | Angiojet Solent Omni Thrombectomy SetQEZ · Special | 05/24/2011SE |
| K100798 | Medrad Intego PET Infusion System, Source Administration Set, Patient Adminstratin Set…FRN · Traditional | 06/23/2010SE |
| K082905 | Medrad Stellant CT Injector System with P3T CardiacDXT · Traditional | 01/12/2009SE |
Questions and answers
When was Medrad Mark 7 Arterion (Pedestal System / Table Mount System), Medrad Mark 7 Arterion Syringe cleared by the FDA?
Medrad Mark 7 Arterion (Pedestal System / Table Mount System), Medrad Mark 7 Arterion Syringe (K112086) received a 510(k) decision of Substantially Equivalent on October 14, 2011, 85 days after the submission was received.
What is the product code of K112086?
The FDA product code is DXT – Injector And Syringe, Angiographic, a Class II (moderate risk) device regulated under 21 CFR 870.1650.