Nmi Picc II
510(k) K093366
Nmi Picc II is a Class II device made by Navilyst Medical, Inc., cleared under FDA 510(k) K093366 on 24 Nov 2009, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK093366 | Date24 Nov 2009 | StatusActive |
Official records
- FDA 510(k) database K093366
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- LJS
- Device class
- Class II
- Regulation
- 21 CFR Part 880.5970
- Advisory committee
- General Hospital
- FDA decision
- SESE Substantially Equivalent
Similar devices
Other devices filed under FDA product code LJS (Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days).
- VYGON DOUBLE LUMEN PICC-CATHETERS (4FR. AND 5FR.) by Vygon Corp.
- Broviac 0600520 by Bard Access Systems, Inc.
- SECURACATH UNIVERSAL by Interrad Medical, Inc.
- ANGIODYNAMICS, INC. MORPHEUS PICC AND PROCEDURE KIT by ANGIODYNAMICS, INC.
- Neonav ECG Tip Location System by Navi Medical Technologies
- VYGON 2 FR EPICUTANEO PUR-CATHETER by Vygon Corp.
- 1.4 FR MAPCATH SENSOR STYLET by Navion Biomedical Corp.
- GROSHONG NXT PICC CATHETERS by C. R. Bard, Inc.
- LIFEVALVE CENTRAL VENOUS CATHTER by Horizon Medical Products, Inc.
- DIRECT ANTIBIOTIC INFUSION KIT by Summit Medical Products, Inc.