FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HEPARIN LOCK FLUSH SOLUTION, USP BD POSIFLUSH HEPARIN LOCK FLUSH SYRINGE
K Number: K090680
·
Decision Jun 10, 2009
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
6
Applicant Total
190
Review Days
86
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Basic Information
- Device Name
- HEPARIN LOCK FLUSH SOLUTION, USP BD POSIFLUSH HEPARIN LOCK FLUSH SYRINGE
- K Number
- K090680
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 880.5200
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Becton, Dickinson & CO
- Date Received
- March 16, 2009
- Decision Date
- June 10, 2009
- Product Code
- NZW
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| NZW | Heparin, Vascular Access Flush | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NZW), ordered by most recent decision date.
BD PosiFlush Heparin Lock Flush Syringe
FDA 510(k)
FDA Class 2
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HEPARIN LOCK / FLUSH SYRINGES
FDA 510(k)
FDA Class 2
·General Hospital
HEPARIN LOCK FLUSH SOLUTION USP, MODELS 504401, 504411, 504505, 505701, 504901, 1710
FDA 510(k)
FDA Class 2
·General Hospital
MEDEFIL'S HEPARIN I.V. FLUSH SYRINGE 1 UNIT/ML; 10 UNITS/ML; AND 100 UNITS/ML IN VARIOUS FILL SIZES
FDA 510(k)
FDA Class 2
·General Hospital
SYREX HEPARIN LOCK FLUSH SYRINGE, 1 UNIT/ML & 2 UNITS/ML
FDA 510(k)
FDA Class 2
·General Hospital
SYREX PRE-FILLED SYRINGE
FDA 510(k)
FDA Class 2
·General Hospital
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