FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EXEL I.V. EXTENSION SET
K Number: K092172
·
Decision Jan 4, 2010
Classifications
1
FEI Numbers
424
Registration Numbers
424
Same Product Code
1173
Applicant Total
12
Review Days
167
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Basic Information
- Device Name
- EXEL I.V. EXTENSION SET
- K Number
- K092172
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Exelint Intl. Co.
- Date Received
- July 21, 2009
- Decision Date
- January 4, 2010
- 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 Exelint Intl. Co.
| K Number | Device Name | ||
|---|---|---|---|
| K052103 | EXEL SECURE TOUCH II SAFETY SYRINGE | Oct 19, 2005 | Substantially Equivalent |
| K031500 | EXCEL PRIMARY SOLUTION SET | Jul 25, 2003 | Substantially Equivalent |
| K011754 | EXEL SECURETOUCH PTP SYRINGE | Jan 22, 2003 | Substantially Equivalent |
| K020533 | EXEL VACULET BLOOD COLLECTION SET | Dec 2, 2002 | Substantially Equivalent |
| K022406 | EXEL SECURETOUCH SAFETY VACULET BLOOD COLLECTION SET | Sep 30, 2002 | Substantially Equivalent |
| K011757 | EXEL COMFORTPOINT INSULIN PEN NEEDLE | Jan 23, 2002 | Substantially Equivalent |
| K012879 | EXEL HUBER INFUSION SET WITH NEEDLELESS INJECTION SITE | Jan 17, 2002 | Substantially Equivalent |
| K013037 | EXCEL A.V FISUTAL NEEDLE SET | Dec 7, 2001 | Substantially Equivalent |
| K011405 | EXEL INJECTION PLUG WITH CAP | Sep 27, 2001 | Substantially Equivalent |
| K010404 | EXEL I.V. ADMINISTRATION SET | Aug 30, 2001 | Substantially Equivalent |