FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NMI CONTROL SYRINGE, 7 ML NMI CONTROL SYRINGE, 8 ML
K Number: K113198
·
Decision Nov 28, 2011
Classifications
1
FEI Numbers
124
Registration Numbers
124
Same Product Code
209
Applicant Total
35
Review Days
28
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
- NMI CONTROL SYRINGE, 7 ML NMI CONTROL SYRINGE, 8 ML
- K Number
- K113198
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.1650
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Navilyst Medical, Inc.
- Date Received
- October 31, 2011
- Decision Date
- November 28, 2011
- 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 Navilyst Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K163452 | PICC Maximal Barrier Nursing Kit | Feb 3, 2017 | Unknown |
| K161866 | BioFlo Midline Catheter | Sep 8, 2016 | Substantially Equivalent |
| K151239 | NMI DUAL PORT II | Jun 6, 2016 | Substantially Equivalent |
| K153228 | NMI Port, NMI Port II | Dec 4, 2015 | Substantially Equivalent |
| K152409 | Xcela PICC with PASV, Xcela Hybrid PICC with PASV, Xcela Power Injectable PICC | Sep 24, 2015 | Substantially Equivalent |
| K152069 | Exodus Array Multipurpose Drainage Catheter, Exodus Nuance Nephrostomy Drainage Catheter, Exodus Believe Biliary Drainage Catheter | Sep 24, 2015 | Substantially Equivalent |
| K150407 | BioFlo Midline Catheter | May 15, 2015 | Substantially Equivalent |
| K150527 | Xcela Power Injectable PICC | Mar 31, 2015 | Substantially Equivalent |
| K150448 | NMI PICC III and NMI PICC IV | Mar 19, 2015 | Substantially Equivalent |
| K142616 | PICC Maximal Barrier Nursing Kit | Oct 14, 2014 | Substantially Equivalent |