FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MODIFIED BIVONA EPISTAXIS CATHETER
K Number: K900583
·
Decision Aug 9, 1990
Classifications
1
FEI Numbers
60
Registration Numbers
60
Same Product Code
46
Applicant Total
50
Review Days
183
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Basic Information
- Device Name
- MODIFIED BIVONA EPISTAXIS CATHETER
- K Number
- K900583
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.4100
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- Bivona Medical Technologies
- Date Received
- February 7, 1990
- Decision Date
- August 9, 1990
- Product Code
- EMX
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- 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 |
|---|---|---|---|
| EMX | Balloon, Epistaxis | FDA class 1 | Ear, Nose, Throat |
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Other Clearances by Bivona Medical Technologies
| K Number | Device Name | ||
|---|---|---|---|
| K952700 | SUPERSLICK | Oct 31, 1995 | Substantially Equivalent |
| K942025 | BURGET NASAL STENT | Oct 27, 1995 | Substantially Equivalent |
| K944178 | BIVONA FLEXTEND PEDIATRIC & NEONATAL TRACHEOSTROMY TUBES | Oct 27, 1994 | Substantially Equivalent |
| K935053 | BIVONA NASAL TURBINATE STENT | Jul 1, 1994 | Substantially Equivalent |
| K933398 | BIVONA ILLUMINATED ENDOTRACHEAL TUBE | Oct 6, 1993 | Substantially Equivalent |
| K931749 | BIVONA(R) ICU ENDOTRACHEAL TUBE | Aug 10, 1993 | Substantially Equivalent |
| K922665 | BIVONA HYPERFLEX TRACHEOSTOMY TUBE | Jan 7, 1993 | Substantially Equivalent |
| K923878 | BIVONA CUSTOMIZED TRACHEOSTOMY TUBES | Dec 29, 1992 | Substantially Equivalent |
| K920604 | BIVONA TRACHEAL T-TUBE STENT | Jul 27, 1992 | Substantially Equivalent |
| K915761 | BIVONA-COLORADO VOICE PROSTHESIS | Jun 29, 1992 | Substantially Equivalent |