FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OPTION EPIDURAL CATHETERS
K Number: K895476
·
Decision Jan 19, 1990
Classifications
1
FEI Numbers
81
Registration Numbers
81
Same Product Code
154
Applicant Total
7
Review Days
130
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Basic Information
- Device Name
- OPTION EPIDURAL CATHETERS
- K Number
- K895476
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5140
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Opticon Medical, Inc.
- Date Received
- September 11, 1989
- Decision Date
- January 19, 1990
- Product Code
- CAZ
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| CAZ | Anesthesia Conduction Kit | FDA class 2 | Anesthesiology |
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Other Clearances by Opticon Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K033830 | OPTION-VF URINARY CATHETER WITH ADAPTOR, MODEL FVA14218; OPTION-V CONTINUOUS DRAINAGE ADAPTOR, MODEL CDA1000 | Jan 9, 2004 | Substantially Equivalent |
| K023090 | OPTION-VF URINARY CATHETER, FV14218 | Mar 19, 2003 | Substantially Equivalent |
| K970716 | OPTICON DIRECT MALE URINARY CATHETER FOR CONTINUOUS DRAINAGE | May 16, 1997 | Substantially Equivalent |
| K930194 | HEMOSTASIS VALVE AND TUBING SET | Sep 22, 1993 | Substantially Equivalent |
| K904999 | WEINGARTEN TM CAPNOGRAPHIC INTUBATION STYLETTE | Jan 26, 1993 | Substantially Equivalent |
| K895955 | LOPER CELIAC PLEXUS BLOCK CATHETER KIT | Feb 22, 1990 | Substantially Equivalent |