FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MENTOR INFUSION LINE
K Number: K912919
·
Decision Dec 13, 1991
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
63
Applicant Total
61
Review Days
163
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Basic Information
- Device Name
- MENTOR INFUSION LINE
- K Number
- K912919
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5130
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Mentor Corp.
- Date Received
- July 3, 1991
- Decision Date
- December 13, 1991
- Product Code
- KNY
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| KNY | Accessories, Catheter, G-U | FDA class 2 | Gastroenterology, Urology |
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| K Number | Device Name | ||
|---|---|---|---|
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| K053414 | MENTOR NOVASILK MESH | Dec 27, 2005 | Substantially Equivalent |
| K050008 | MENTOR SELF-CATH HYDROGEL INTERMITTENT CATHETER | Jun 3, 2005 | Substantially Equivalent |
| K042851 | MENTOR OBTAPE TRANS-OBTURATOR SURGICAL KIT | Nov 9, 2004 | Substantially Equivalent |
| K040959 | MENTOR GENESIS PENILE PROSTHESIS | Oct 29, 2004 | Substantially Equivalent |
| K031767 | MENTOR OBTAPE TRANS-OBTURATOR TAPE | Jul 17, 2003 | Substantially Equivalent |
| K011493 | MENTOR ISOLOADER AUTOMATIC NEEDLE LOADING SYSTEM AND PHYSICS WORKSTATION FOR BRACHYTHERAPY | Oct 1, 2002 | Substantially Equivalent |
| K011500 | MENTOR CONTOUR PROFILE TISSUE EXPANDER | Dec 3, 2001 | Substantially Equivalent |
| K004005 | MENTOR ULTRASOUND-ASSISTED TISSUE REMOVAL SYSTEM (CURRENT), MENTOR CONTOUR GENESIS SYSTEM (PROPOSED) | Oct 12, 2001 | Substantially Equivalent |
| K010709 | MENTOR STERILE SALINE MAMMARY VOLUME SIZERS | Apr 23, 2001 | Substantially Equivalent |