OPTION-VM URINARY CATHETER/ADPATER, MODELS MV39016, MVA39016
FDA 510(k) clearance K041983 · decided 2004-11-17
Clearance details
- K-number
- K041983
- Device name
- OPTION-VM URINARY CATHETER/ADPATER, MODELS MV39016, MVA39016
- Applicant
- Opticon Medical
- Decision
- Substantially Equivalent
- Date received
- 2004-07-23
- Decision date
- 2004-11-17
- Days to decision
- 117 days
- Clearance type
- Traditional
- Product code
- EZL
- Device class
- 2
- Regulation number
- 876.5130
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Dublin, OH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Option-vm Urinary Catheter. Male use only. Latex Free. Sterile, Rx only. recall (Z-2831-2016) | C.R. Bard, Inc. | 2016-09-15 |