NMI CONTROL SYRINGE, 7 ML NMI CONTROL SYRINGE, 8 ML
FDA 510(k) clearance K113198 · decided 2011-11-28
Clearance details
- K-number
- K113198
- Device name
- NMI CONTROL SYRINGE, 7 ML NMI CONTROL SYRINGE, 8 ML
- Applicant
- Navilyst Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2011-10-31
- Decision date
- 2011-11-28
- Days to decision
- 28 days
- Clearance type
- Special
- Product code
- DXT
- Device class
- 2
- Regulation number
- 870.1650
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Marlborough, MA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Navilyst Medical
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| NAMIC Angiographic Control Syringe, labeled as follows: 1. SYRINGE,7ML,TR/FR,RA,W/RES,-,P/ recall (Z-1713-2026) | Medline Industries, LP | 2026-04-07 |