FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CT 8000 DIGITAL INJECTION SYSTEM
K Number: K912944
·
Decision Feb 4, 1992
Classifications
1
FEI Numbers
124
Registration Numbers
124
Same Product Code
209
Applicant Total
27
Review Days
214
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- CT 8000 DIGITAL INJECTION SYSTEM
- K Number
- K912944
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1650
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Mallinckrodt Group, Inc.
- Date Received
- July 5, 1991
- Decision Date
- February 4, 1992
- Product Code
- DXT
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DXT | Injector And Syringe, Angiographic | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DXT), ordered by most recent decision 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
FDA 510(k)
FDA Class 2
·Cardiovascular
ACIST Pro Diagnostic System (019304); Processing Unit Bed Mount; AngioTouch Module; ACIST Pro Cart; Single Transducer Cable; Triple Transducer Cable
FDA 510(k)
FDA Class 2
·Cardiovascular
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)
FDA 510(k)
FDA Class 2
·Cardiovascular
High Pressure Syringe; Pressure Connecting Tube; Quick fill tube; Spike; Transfer Tube
FDA 510(k)
FDA Class 2
·Cardiovascular
Extension tube
FDA 510(k)
FDA Class 2
·Cardiovascular
MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD ISI2 Module (ISI2)
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Mallinckrodt Group, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K945053 | LF CT HIG PRESSURE CATHETERS | May 19, 1995 | Substantially Equivalent |
| K945140 | URO-FLO | Mar 8, 1995 | Substantially Equivalent |
| K943581 | HYDRADJUST IV UROLOGICAL TABLE | Jan 4, 1995 | Substantially Equivalent |
| K943122 | SURGICAL DRAPES | Sep 7, 1994 | Substantially Equivalent |
| K934664 | HYDRAGOWN | May 24, 1994 | Substantially Equivalent |
| K920742 | HYDRAJUST IV UROLOGICAL TABLE | Apr 27, 1992 | Substantially Equivalent |
| K913264 | HYDRAVIEW 1000 DIGITAL IMAGE PROCESS/STOR DEVICE | Nov 1, 1991 | Substantially Equivalent |
| K905789 | FRANKLIN 9000 WALL STAND | May 20, 1991 | Substantially Equivalent |
| K904147 | HUGH YOUNG II UROLOGICAL X-RAY SYSTEM | Dec 13, 1990 | Substantially Equivalent |
| K904145 | HYDRA VISION UROLOGICAL X-RAY SYSTEM | Dec 13, 1990 | Substantially Equivalent |