FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SYREX PRE-FILLED SYRINGE
K Number: K023740
·
Decision May 13, 2003
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
6
Applicant Total
9
Review Days
187
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Basic Information
- Device Name
- SYREX PRE-FILLED SYRINGE
- K Number
- K023740
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5200
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Excelsior Medical Corp.
- Date Received
- November 7, 2002
- Decision Date
- May 13, 2003
- 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
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HEPARIN LOCK FLUSH SOLUTION USP, MODELS 504401, 504411, 504505, 505701, 504901, 1710
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MEDEFIL'S HEPARIN I.V. FLUSH SYRINGE 1 UNIT/ML; 10 UNITS/ML; AND 100 UNITS/ML IN VARIOUS FILL SIZES
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HEPARIN LOCK FLUSH SOLUTION, USP BD POSIFLUSH HEPARIN LOCK FLUSH SYRINGE
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FDA Class 2
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SYREX HEPARIN LOCK FLUSH SYRINGE, 1 UNIT/ML & 2 UNITS/ML
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 |
| K061497 | SYREX HEPARIN LOCK FLUSH SYRINGE, 1 UNIT/ML & 2 UNITS/ML | Feb 23, 2007 | Substantially Equivalent |
| K053120 | STERILE FIELD SALINE AND HEPARIN LOCK FLUSH SYRINGES | Dec 9, 2005 | 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 |