DRAINAGE CATHETERS W/A DISSOLVABLE TIP
FDA 510(k) clearance K900205 · decided 1991-08-20
Clearance details
- K-number
- K900205
- Device name
- DRAINAGE CATHETERS W/A DISSOLVABLE TIP
- Applicant
- Boston Scientific Corp
- Decision
- Substantially Equivalent
- Date received
- 1990-01-16
- Decision date
- 1991-08-20
- Days to decision
- 581 days
- Clearance type
- Traditional
- Product code
- FGE
- Device class
- 2
- Regulation number
- 876.5010
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- San Jose, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style) UPN# DES recall (Z-1341-2009) | Boston Scientific Corporation | 2009-05-21 |
| Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style) UPN# DES recall (Z-1343-2009) | Boston Scientific Corporation | 2009-05-21 |