AVD INTIMAX (TM) BILIARY CATHETER
FDA 510(k) clearance K910006 · decided 1991-02-13
Clearance details
- K-number
- K910006
- Device name
- AVD INTIMAX (TM) BILIARY CATHETER
- Applicant
- Applied Vascular
- Decision
- Substantially Equivalent
- Date received
- 1991-01-02
- Decision date
- 1991-02-13
- Days to decision
- 42 days
- Clearance type
- Traditional
- Product code
- FGE
- Device class
- 2
- Regulation number
- 876.5010
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Launa Hills, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Biliary Catheters (Models A47XX and CB0XXXXX): Model Numbers & Description: A4752, SYNTEL recall (Z-2447-2012) | Applied Medical Resources Corp | 2012-09-25 |