FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SYREX HEPARIN LOCK FLUSH SYRINGE, 1 UNIT/ML & 2 UNITS/ML
K Number: K061497
·
Decision Feb 23, 2007
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
6
Applicant Total
9
Review Days
268
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Basic Information
- Device Name
- SYREX HEPARIN LOCK FLUSH SYRINGE, 1 UNIT/ML & 2 UNITS/ML
- K Number
- K061497
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5200
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Excelsior Medical Corp.
- Date Received
- May 31, 2006
- Decision Date
- February 23, 2007
- 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
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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
HEPARIN LOCK FLUSH SOLUTION, USP BD POSIFLUSH HEPARIN LOCK FLUSH SYRINGE
FDA 510(k)
FDA Class 2
·General Hospital
SYREX PRE-FILLED SYRINGE
FDA 510(k)
FDA Class 2
·General Hospital
Other Clearances by Excelsior Medical Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K130975 | SWABCAP AND SWABFLUSH | Dec 24, 2013 | Substantially Equivalent |
| K101270 | SWABFLSUH (3ML, 5ML, 10ML) MODEL 10331, 10351, 10311 | Feb 10, 2011 | Substantially Equivalent |
| K083508 | SWABCAP | Apr 28, 2009 | Substantially Equivalent |
| K082837 | STERILE FIELD SALINE PRE-FILLED SYRINGE(S) | Dec 18, 2008 | Substantially Equivalent |
| K053120 | STERILE FIELD SALINE AND HEPARIN LOCK FLUSH SYRINGES | Dec 9, 2005 | Substantially Equivalent |
| K023740 | SYREX PRE-FILLED SYRINGE | May 13, 2003 | Substantially Equivalent |
| K962938 | EXCELSIOR DISPOSABLE SYRINGE W/NORMAL SALINE (.9% SODIUM CHLORIDE) | Oct 25, 1996 | Substantially Equivalent |
| K942349 | MICROBORE EXTENSION SET | Feb 8, 1995 | Substantially Equivalent |