FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MENTOR DUCTAL CATHETERS
K Number: K895285
·
Decision Oct 17, 1989
Classifications
1
FEI Numbers
57
Registration Numbers
57
Same Product Code
23
Applicant Total
61
Review Days
54
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Basic Information
- Device Name
- MENTOR DUCTAL CATHETERS
- K Number
- K895285
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4200
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Mentor Corp.
- Date Received
- August 24, 1989
- Decision Date
- October 17, 1989
- Product Code
- GBZ
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| GBZ | Catheter, Cholangiography | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GBZ), ordered by most recent decision date.
PRE-VIEW CHOLANGIOGRAPHY CLAMP
FDA 510(k)
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FLEXIBLE LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER
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ENDOPATH
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
MICROVASIVE INSURG CHLOANGIOGRAPHIC CATHETER
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FDA Class 1
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TERUMO ANGIOGRAPHIC CATHETER FOR LAPOROSCOPIC USE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
STRYKER ENDOSCOPY CHOLANGIOGRAM KIT
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
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