510(k) K090680
- Device
- HEPARIN LOCK FLUSH SOLUTION, USP BD POSIFLUSH HEPARIN LOCK FLUSH SYRINGE
- Applicant
- BECTON DICKINSON & CO.
- 510(k) number
- K090680
- Product code
- NZW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2009-06-10
- Date received
- 2009-03-16
- Regulation
- 880.5200
- Classification name
- Heparin, Vascular Access Flush
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JOHN ROBERTS
- Address
- 1 Becton Dr. Mc 237 Franklin Lakes NJ US 07417 07417
FDA Registration Numbers#
- 1423982
- 3011689956
- 3008518459
- 3012421607
- 2243072
- 2027791
- 1911916
- 1423507
Source Documents#
Other 510(k) Records For Product Code NZW #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K163591 | BD PosiFlush Heparin Lock Flush Syringe | Becton, Dickinson and Company | 2017-02-27 |
| K133446 | HEPARIN LOCK / FLUSH SYRINGES | Excelsior Medical Corporation | 2014-11-14 |
| K092938 | HEPARIN LOCK FLUSH SOLUTION USP, MODELS 504401, 504411, 504505, 505701, 504901, 1710 | App Pharmaceuticals, LLC | 2010-06-18 |
| K092491 | MEDEFIL'S HEPARIN I.V. FLUSH SYRINGE 1 UNIT/ML; 10 UNITS/ML; AND 100 UNITS/ML IN VARIOUS FILL SIZES | Medefil, Inc. | 2010-02-03 |
| K061497 | SYREX HEPARIN LOCK FLUSH SYRINGE, 1 UNIT/ML & 2 UNITS/ML | Excelsior Medical Corp. | 2007-02-23 |
| K023740 | SYREX PRE-FILLED SYRINGE | Excelsior Medical Corp. | 2003-05-13 |
Legacy Summary#
summary
FDA Review#
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