FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OLYMPUS ANGIOSCOPY IRRIGATION SHEATH
K Number: K910933
·
Decision Jun 3, 1991
Classifications
1
FEI Numbers
273
Registration Numbers
273
Same Product Code
701
Applicant Total
142
Review Days
89
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Basic Information
- Device Name
- OLYMPUS ANGIOSCOPY IRRIGATION SHEATH
- K Number
- K910933
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1340
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Olympus Corp.
- Date Received
- March 6, 1991
- Decision Date
- June 3, 1991
- Product Code
- DYB
- 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 |
|---|---|---|---|
| DYB | Introducer, Catheter | FDA class 2 | Cardiovascular |
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| K934835 | FLOVAL | Jun 21, 1994 | Substantially Equivalent |
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| K931994 | RESECTOSCOPE SHEATH | Feb 17, 1994 | Substantially Equivalent |
| K933992 | OLYMPUS SCLEROTHERAPY BALLOON | Dec 21, 1993 | Substantially Equivalent |
| K934361 | OLYMPUS CREATININE REAGENT | Nov 16, 1993 | Substantially Equivalent |