CT Syringe for Stellant Injectors (with & without Spikes, Prime Tubes, & Fill Tubes), CT Syringe Dual Pack for Stellant Injectors (with & without Spikes, Prime Tubes, & Fill Tubes), Single Fascia and Ram Tip, Dual Fascia and Ram Tip
FDA 510(k) clearance K170431 · decided 2017-08-18
Clearance details
- K-number
- K170431
- Device name
- CT Syringe for Stellant Injectors (with & without Spikes, Prime Tubes, & Fill Tubes), CT Syringe Dual Pack for Stellant Injectors (with & without Spikes, Prime Tubes, & Fill Tubes), Single Fascia and Ram Tip, Dual Fascia and Ram Tip
- Applicant
- Coeur, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2017-02-13
- Decision date
- 2017-08-18
- Days to decision
- 186 days
- Clearance type
- Traditional
- Product code
- DXT
- Device class
- 2
- Regulation number
- 870.1650
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Lebanon, TN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|
| Disposable Syringes with Accessories for Power Injectors (900103T); Disposable Syringes with Accessories for Power Injectors (900103H); Disposable Syringes with Accessories for Power Injectors (801800H); Disposable Syringes with Accessories for Power Injectors (800099T); Disposable Syringes with Accessories for Power Injectors (800099H); Disposable Syringes with Accessories for Power Injectors (800096T); Disposable Syringes with Accessories for Power Injectors (800096H); Disposable Syr (K252652) | Fortis Biosolutions Company Limited | 2026-05-14 |
| ACIST Pro Diagnostic System (019304); Processing Unit Bed Mount; AngioTouch Module; ACIST Pro Cart; Single Transducer Cable; Triple Transducer Cable (K252653) | Acist Medical Systems, Inc. | 2026-05-13 |
| VeraPro S100 Multi-Use Syringe (018808); VeraPro S100 LV1 Low Viscosity Single-Use Syringe (018811); VeraPro AMT Auto-Manifold and Transducer (018814); VeraPro AngioTouch FLX165 Hand Controller Kit (018806); VeraPro AngioTouch HiFi165 Hand Controller Kit (018804) (K252638) | Acist Medical Systems, Inc. | 2026-05-13 |
| High Pressure Syringe; Pressure Connecting Tube; Quick fill tube; Spike; Transfer Tube (K253048) | Shenzhen Maiwei Biotech Co., Ltd. | 2026-04-16 |
| Extension tube (K251788) | Zhuhai DR Medical Instruments Co., Ltd. | 2026-03-05 |
| MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD ISI2 Module (ISI2) (K252891) | Bayer Medical Care, Inc. | 2026-02-13 |
| High Pressure Tubing (K244038) | Shandong Int Medical Instruments Co., Ltd. | 2025-09-05 |
| Angiography Injector (K242143) | Shandong Int Medical Instruments Co., Ltd. | 2024-12-23 |
| Disposable Syringe (Kit); Nemoto Disposable Syringe (Kit) (K242212) | Nemoto Kyorindo Co., Ltd. | 2024-08-27 |
| Single-use Sterile High-pressure Angiographic Syringes and Accessories (K241109) | Shenzhen Boon Medical Supply Co., Ltd. | 2024-08-22 |
| Disposable High-pressure Extension Lines (K230668) | Precision Medical Plastics , Ltd. | 2024-06-14 |
| High Pressure Tubing (K232388) | Ningbo Dizegens Medical Science Co.,Ltd | 2023-11-21 |
Recalls involving this device
No recalls on record reference this clearance.