HEMOSTASIS VALVE AND TUBING SET— 510(k) K930194
Substantially EquivalentOpticon Medical, Inc.
FDA 510(k) clearance K930194 for HEMOSTASIS VALVE AND TUBING SET, Substantially Equivalent on 1993-09-22. Applicant: Opticon Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Opticon Medical, Inc.
- Product code
- Code DYB
- Device class
- Class 2
- Regulation
- 21 CFR 870.1340
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Gurnee, IL, US
Recent devices under product code DYB
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
- K904999 — WEINGARTEN TM CAPNOGRAPHIC INTUBATION STYLETTE
- K895955 — LOPER CELIAC PLEXUS BLOCK CATHETER KIT
Adverse events under product code DYB
product code DYB- Death
- 808
- Injury
- 5,922
- Malfunction
- 16,516
- Other
- 5
- Total
- 23,251
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.