NZW · Heparin, Vascular Access Flush
General Hospital · 21 CFR 880.5200 · Class 2
Overview
| Product Code | NZW |
|---|---|
| Device Name | Heparin, Vascular Access Flush |
| Regulation | 21 CFR 880.5200 |
| Device Class | Class 2 |
| Review Panel | General Hospital |
Identification
An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (7 of 7)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K163591 | BD PosiFlush Heparin Lock Flush Syringe | Becton, Dickinson and Company | Feb 27, 2017 | SESE |
| K133446 | HEPARIN LOCK / FLUSH SYRINGES | Excelsior Medical Corporation | Nov 14, 2014 | SESE |
| K092938 | HEPARIN LOCK FLUSH SOLUTION USP, MODELS 504401, 504411, 504505, 505701, 504901, 1710 | App Pharmaceuticals, LLC | Jun 18, 2010 | SESE |
| K092491 | MEDEFIL'S HEPARIN I.V. FLUSH SYRINGE 1 UNIT/ML; 10 UNITS/ML; AND 100 UNITS/ML IN VARIOUS FILL SIZES | Medefil, Inc. | Feb 3, 2010 | SESE |
| K090680 | HEPARIN LOCK FLUSH SOLUTION, USP BD POSIFLUSH HEPARIN LOCK FLUSH SYRINGE | Becton, Dickinson & CO | Jun 10, 2009 | SESE |
| K061497 | SYREX HEPARIN LOCK FLUSH SYRINGE, 1 UNIT/ML & 2 UNITS/ML | Excelsior Medical Corp. | Feb 23, 2007 | SESE |
| K023740 | SYREX PRE-FILLED SYRINGE | Excelsior Medical Corp. | May 13, 2003 | SESE |
Top Applicants
- Excelsior Medical Corp. — 2 clearances
- App Pharmaceuticals, LLC — 1 clearance
- Becton, Dickinson & CO — 1 clearance
- Becton, Dickinson and Company — 1 clearance
- Excelsior Medical Corporation — 1 clearance
