FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MEDISYSTEMS LUER ACCESS INJECTION SITE
K Number: K010279
·
Decision May 29, 2001
Classifications
1
FEI Numbers
424
Registration Numbers
424
Same Product Code
1173
Applicant Total
22
Review Days
119
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Basic Information
- Device Name
- MEDISYSTEMS LUER ACCESS INJECTION SITE
- K Number
- K010279
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medisystems Corp.
- Date Received
- January 30, 2001
- Decision Date
- May 29, 2001
- Product Code
- FPA
- 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 |
|---|---|---|---|
| FPA | Set, Administration, Intravascular | FDA class 2 | General Hospital |
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Other Clearances by Medisystems Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K062953 | MEDISYSTEMS ARTERIAL-VENOUS FISTULA NEEDLE SET WITH SECUREMENT DEVICE | Feb 12, 2007 | Substantially Equivalent |
| K002372 | ACCESS ALERT GAUGE | Oct 25, 2000 | Substantially Equivalent |
| K994306 | REVERSO | Mar 20, 2000 | Substantially Equivalent |
| K990803 | MEDISYSTEMS BUTTONHOLE NEEDLE SETS | Jan 6, 2000 | Substantially Equivalent |
| K983076 | MEDISYSTEMS TRANSDUCER PROTECTOR | Nov 25, 1998 | Substantially Equivalent |
| K971860 | MEDISYSTEMS DIALYSIS PRIMING SETS | Aug 18, 1997 | Substantially Equivalent |
| K963668 | MEDISYSTEMS PERITONEAL DIALYSIS SETS | Aug 15, 1997 | Substantially Equivalent |
| K970536 | MEDISYSTEMS TRANDUCER PROTECTOR | May 12, 1997 | Substantially Equivalent |
| K953823 | ARTERIAL VENOUS BLOOD TUBING SET | Sep 23, 1996 | Substantially Equivalent |
| K932074 | MEDISYSTEMS APHERESIS NEEDLE WITH GUARD | Feb 18, 1994 | Substantially Equivalent |