FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OPTICAL VALVULOTOME
K Number: K914385
·
Decision Mar 2, 1992
Classifications
1
FEI Numbers
12
Registration Numbers
12
Same Product Code
26
Applicant Total
14
Review Days
153
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Basic Information
- Device Name
- OPTICAL VALVULOTOME
- K Number
- K914385
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4885
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Intramed Laboratories, Inc.
- Date Received
- October 1, 1991
- Decision Date
- March 2, 1992
- Product Code
- MGZ
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| MGZ | Valvulotome | FDA class 2 | Cardiovascular |
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Other Clearances by Intramed Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K953258 | TITANIUM HEMOSTATIC CLIP | Jan 5, 1996 | Substantially Equivalent |
| K942457 | GRAFT THROMBECTOMY INSTRUMENTS | Feb 7, 1995 | Substantially Equivalent |
| K931792 | ARTHROSCOPE | Jun 13, 1994 | Substantially Equivalent |
| K925283 | VALVULOTOME | Feb 10, 1994 | Substantially Equivalent |
| K934696 | ANGIOSCOPE | Jan 18, 1994 | Substantially Equivalent |
| K922114 | ENDOSCOPIC RETRIEVAL BASKET | Aug 3, 1992 | Substantially Equivalent |
| K904465 | FLEXIBLE ARTHROSCOPE | Dec 20, 1990 | Substantially Equivalent |
| K903528 | LAPAROSCOPE | Sep 4, 1990 | Substantially Equivalent |
| K902444 | CLEARVIEW(TM) ANGIOSCOPIC IRRIGATION PUMP | Aug 30, 1990 | Substantially Equivalent |
| K901010 | FLEXIBLE CHOLEDOCHOSCOPE | May 22, 1990 | Substantially Equivalent |