OPTION EPIDURAL CATHETERS— 510(k) K895476
Substantially EquivalentOpticon Medical, Inc.
FDA 510(k) clearance K895476 for OPTION EPIDURAL CATHETERS, Substantially Equivalent on 1990-01-19. Applicant: Opticon Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Opticon Medical, Inc.
- Product code
- Code CAZ
- Device class
- Class 2
- Regulation
- 21 CFR 868.5140
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Gurnee, IL, US
Recent devices under product code CAZ
view allMore clearances from Opticon Medical, Inc.
view all- K033830 — OPTION-VF URINARY CATHETER WITH ADAPTOR, MODEL FVA14218; OPTION-V CONTINUOUS DRAINAGE ADAPTOR, MODEL CDA1000
- K023090 — OPTION-VF URINARY CATHETER, FV14218
- K970716 — OPTICON DIRECT MALE URINARY CATHETER FOR CONTINUOUS DRAINAGE
- K930194 — HEMOSTASIS VALVE AND TUBING SET
- K904999 — WEINGARTEN TM CAPNOGRAPHIC INTUBATION STYLETTE
Adverse events under product code CAZ
product code CAZ- Injury
- 145
- Malfunction
- 942
- Other
- 1
- Total
- 1,088
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.