SYREX HEPARIN LOCK FLUSH SYRINGE, 1 UNIT/ML & 2 UNITS/ML
FDA 510(k) clearance K061497 · decided 2007-02-23
Clearance details
- K-number
- K061497
- Device name
- SYREX HEPARIN LOCK FLUSH SYRINGE, 1 UNIT/ML & 2 UNITS/ML
- Applicant
- Excelsior Medical Corp.
- Decision
- Substantially Equivalent
- Date received
- 2006-05-31
- Decision date
- 2007-02-23
- Days to decision
- 268 days
- Clearance type
- Traditional
- Product code
- NZW
- Device class
- 2
- Regulation number
- 880.5200
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Neptune, NJ, US
- Third-party review
- No
- Expedited review
- No
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| Record | Firm | Date |
|---|---|---|
| BD PosiFlush Heparin Lock Flush Syringe (K163591) | Becton, Dickinson and Company | 2017-02-27 |
| HEPARIN LOCK / FLUSH SYRINGES (K133446) | Excelsior Medical Corporation | 2014-11-14 |
| HEPARIN LOCK FLUSH SOLUTION USP, MODELS 504401, 504411, 504505, 505701, 504901, 1710 (K092938) | App Pharmaceuticals, LLC | 2010-06-18 |
| MEDEFIL'S HEPARIN I.V. FLUSH SYRINGE 1 UNIT/ML; 10 UNITS/ML; AND 100 UNITS/ML IN VARIOUS FILL SIZES (K092491) | Medefil, Inc. | 2010-02-03 |
| HEPARIN LOCK FLUSH SOLUTION, USP BD POSIFLUSH HEPARIN LOCK FLUSH SYRINGE (K090680) | Becton, Dickinson & CO | 2009-06-10 |
| SYREX PRE-FILLED SYRINGE (K023740) | Excelsior Medical Corp. | 2003-05-13 |